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8. Propensity Score and Desirability of Outcome Ranking Analysis of Ertapenem for Treatment of Nonsevere Bacteremic Urinary Tract Infections Due to Extended-Spectrum-Beta-Lactamase-Producing Enterobacterales in Kidney Transplant Recipients

Author

Gutierrez-Gutierrez, B., Perez-Nadales, E., Perez-Galera, S., Fernandez-Ruiz, M., Carratala, J., Oriol, I., Cordero, E., Lepe, J. A., Tan, B. H., Corbella, L., Paul, M., Natera, A. M., David, M. D., Montejo, M., Iyer, R. N., Pierrotti, L. C., Merino, E., Steinke, S. M., Rana, M. M., Munoz, P., Mularoni, A., van Delden, C., Grossi, P. A., Seminari, E. M., Gunseren, F., Lease, E. D., Roilides, E., Fortun, J., Arslan, H., Coussement, J., Tufan, Z. K., Pilmis, B., Rizzi, M., Loeches, B., Eriksson, B. M., Abdala, E., Soldani, F., Lowman, W., Clemente, W. T., Bodro, M., Farinas, M. C., Kazak, E., Martinez-Martinez, L., Aguado, J. M., Torre-Cisneros, J., Pascual, A., Rodriguez-Bano, J., Sabe, N., Camoez, M., Martin-Gandul, C., Bernal, G., Kee, T. Y. S., Lopez-Medrano, F., Juan, R. S., Koppel, F., Bar-Sinai, N., Caston, J. J., Cano, A., Gracia-Ahufinger, I., Rodriguez, R., Lopez-Soria, L., Azurmendi, M., Pinheiro, M., Freire, M., Banks, I., Lopes, F., David-Neto, E., Balibrea, N., Franco, A., Avery, R., Ostrander, D., Minero, M. V., Carrillo, C. S., Rodriguez-Ferrero, M. L., Monaco, F., Campanella, M., Mueller, N. J., Manuel, O., Khanna, N., Rovelli, C., Balsamo, M. L., Colombo, A., Leoni, C., Pyrpasopoulou, A., Mouloudi, E., Iosifidis, E., Martin-Davila, P., Gioia, F., Escudero, R., Demirkaya, M. H., Dewispelaere, L., Kalem, A. K., Hasanoglu, I., Guner, R., Lortholary, O., Scemla, A., Calvi, E. G., Gervasi, E., Binda, F., Oliva, M. L., Dimopoulos, N., Magalhaes, M. R., Song, A. T. W., D'Albuquerque, L. A. C., Chiesi, S., Salerno, N. D., Mourao, P. H. O., Moreno, A., Linares, L., Almela, M., Rico, C. G., Rodrigo, E., Martinez, M. F., Falcone, M., Tumbarello, M., Strabelli, T. M. V., Instituto de Salud Carlos III, Ministerio de Ciencia, Innovación y Universidades (España), Red Española de Investigación en Patología Infecciosa, European Commission, Sociedad Andaluza de Trasplante de Órganos y Tejidos, and Ministerio de Ciencia e Innovación (España)

Subjects
Ertapenem, medicine.medical_specialty, Urinary system, UTI, Bacteremia, Bloodstream infection, BSI, Logistic regression, Extended-spectrum-b-lactamase-producing Enterobacterales, Meropenem, beta-Lactamases, Cohort Studies, chemistry.chemical_compound, Internal medicine, polycyclic compounds, medicine, Humans, Pharmacology (medical), Propensity Score, Kidney transplant, Retrospective Studies, Pharmacology, Urinary tract infection, business.industry, ESBL-E, Anti-Bacterial Agents, Kidney Transplantation, Urinary Tract Infections, bacterial infections and mycoses, medicine.disease, Infectious Diseases, chemistry, Propensity score matching, Cohort, business, medicine.drug, Cohort study
Abstract

REIPI/ESGICH/ESGBIS/INCREMENT-SOT Group., There are scarce data on the efficacy of ertapenem in the treatment of bacteremia due to extended-spectrum-beta-lactamase (ESBL)-producing Enterobacterales (ESBL-E) in kidney transplant (KT) recipients. We evaluated the association between treatment with ertapenem or meropenem and clinical cure in KT recipients with nonsevere bacteremic urinary tract infections (B-UTI) caused by ESBL-E. We performed a registered, retrospective, international (29 centers in 14 countries) cohort study (INCREMENT-SOT, NCT02852902). The association between targeted therapy with ertapenem versus meropenem and clinical cure at day 14 (the principal outcome) was studied by logistic regression. Propensity score matching and desirability of outcome ranking (DOOR) analyses were also performed. A total of 201 patients were included; only 1 patient (treated with meropenem) in the cohort died. Clinical cure at day 14 was reached in 45/100 (45%) and 51/101 (50.5%) of patients treated with ertapenem and meropenem, respectively (adjusted OR 1.29; 95% CI 0.51 to 3.22; P = 0.76); the propensity score-matched cohort included 55 pairs (adjusted OR for clinical cure at day 14, 1.18; 95% CI 0.43 to 3.29; P = 0.74). In this cohort, the proportion of cases treated with ertapenem with better DOOR than with meropenem was 49.7% (95% CI, 40.4 to 59.1%) when hospital stay was considered. It ranged from 59 to 67% in different scenarios of a modified (weights-based) DOOR sensitivity analysis when potential ecological advantage or cost was considered in addition to outcome. In conclusion, targeted therapy with ertapenem appears as effective as meropenem to treat nonsevere B-UTI due to ESBL-E in KT recipients and may have some advantages., This work was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III (ISCIII), Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001, RD16/0016/0002, RD16/0016/0008; RD16/0016/00010) and was cofinanced by the European Development Regional Fund “A way to achieve Europe,” Operative program Intelligent Growth 2014‐2020; ESCMID Study Group for Infections in Compromised Hosts (ESGICH grant to J.M.A.); Sociedad Andaluza de Trasplante de Órgano Sólido (SATOT grant to L.M.-M.); ESCMID Study Group for Bloodstream Infections and Sepsis (ESGBIS); and ESCMID Study Group for Antimicrobial Resistance Surveillance (ESGARS). B.G.-G. (PI 18/01849) and E.P.-N. (PI 16/01631) have received research funds from the Spanish Ministry of Science and Innovation, ISCIII; M.F.-R. holds a research contract “Miguel Servet” (CP 18/00073) from the Spanish Ministry of Science and Innovation, ISCIII.

Published
2021

10. Propensity Score and Desirability of Outcome Ranking Analysis of Ertapenem for Treatment of Nonsevere Bacteremic Urinary Tract Infections Due to Extended-Spectrum-Beta-Lactamase-Producing Enterobacterales in Kidney Transplant Recipients

Author

Gutierrez-Gutierrez B, Perez-Nadales E, Perez-Galera S, Fernandez-Ruiz M, Carratala J, Oriol I, Cordero E, Lepe J, Tan B, Corbella L, Paul M, Natera A, David M, Montejo M, Iyer R, Pierrotti L, Merino E, Steinke S, Rana M, Munoz P, Mularoni A, van Delden C, Grossi P, Seminari E, Gunseren F, Lease E, Roilides E, Fortun J, Arslan H, Coussement J, Tufan Z, Pilmis B, Rizzi M, Loeches B, Eriksson B, Abdala E, Soldani F, Lowman W, Clemente W, Bodro M, Farinas M, Kazak E, Martinez-Martinez L, Aguado J, Torre-Cisneros J, Pascual A, Rodriguez-Bano J, and Investigators REIPI ESGICH ESGBIS

Subjects
kidney transplant, ertapenem, UTI, bloodstream infection, BSI, urinary tract infection, extended-spectrum-beta-lactamase-producing Enterobacterales, ESBL-E
Abstract

There are scarce data on the efficacy of ertapenem in the treatment of bacteremia due to extended-spectrum-beta-lactamase (ESBL)-producing Enterobacterales (ESBL-E) in kidney transplant (KT) recipients. We evaluated the association between treatment with ertapenem or meropenem and clinical cure in KT recipients with nonsevere bacteremic urinary tract infections (B-UTI) caused by ESBL-E. We performed a registered, retrospective, international (29 centers in 14 countries) cohort study (INCREMENT-SOT, NCT02852902). The association between targeted therapy with ertapenem versus meropenem and clinical cure at day 14 (the principal outcome) was studied by logistic regression. Propensity score matching and desirability of outcome ranking (DOOR) analyses were also performed. A total of 201 patients were included; only 1 patient (treated with meropenem) in the cohort died. Clinical cure at day 14 was reached in 45/100 (45%) and 51/101 (50.5%) of patients treated with ertapenem and meropenem, respectively (adjusted OR 1.29; 95% CI 0.51 to 3.22; P = 0.76); the propensity score-matched cohort included 55 pairs (adjusted OR for clinical cure at day 14, 1.18; 95% CI 0.43 to 3.29; P = 0.74). In this cohort, the proportion of cases treated with ertapenem with better DOOR than with meropenem was 49.7% (95% CI, 40.4 to 59.1%) when hospital stay was considered. It ranged from 59 to 67% in different scenarios of a modified (weights-based) DOOR sensitivity analysis when potential ecological advantage or cost was considered in addition to outcome. In conclusion, targeted therapy with ertapenem appears as effective as meropenem to treat nonsevere B-UTI due to ESBL-E in KT recipients and may have some advantages.

Published
2021

13. Influenza vaccination during the first 6 months after solid organ transplantation is efficacious and safe

Author

Alamo, J.M., Gasch, A., Gentil-Govantes, M.A., Molina-Ortega, F.J., Lage, E., Martínez-Atienza, J., Sánchez, M., Rosso, C., Arizón, J.M., Aguera, M., Cantisán, S., Montero, J.L., Páez, A., Rodríguez, A., Santos, S., Vidal, E., Berasategui, C., Campins, M., López-Meseguer, M., Saez, B., Marcos, M.A., Sanclemente, G., Diez, N., Goikoetxea, J., Casafont, F., Cobo-Beláustegy, M., Durán, R., Fábrega-García, E., Fernández-Rozas, S., González-Rico, C., Zurbano-Goñi, F., Bodro, M., Niubó, J., Oriol, S., Sabé, N., Anaya, F., Bouza, E., Catalán, P., Diez, P., Eworo, A., Kestler, M., Lopez-Roa, P., Rincón, D., Rodríguez, M., Salcedo, M., Sousa, Y., Valerio, M., Morales-Barroso, I., Aguado, J.M., Origuen, J., Pérez-Romero, P., Bulnes-Ramos, A., Torre-Cisneros, J., Gavaldá, J., Aydillo, T.A., Moreno, A., Montejo, M., Fariñas, M.C., Carratalá, J., Muñoz, P., Blanes, M., Fortún, J., Suárez-Benjumea, A., López-Medrano, F., Barranco, J.L., Peghin, M., Roca, C., Lara, R., and Cordero, E.

Published
2015
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14. Role of age and comorbidities in mortality of patients with infective endocarditis

Author

Armiñanzas, C., Fariñas-Alvarez, C., Zarauza, J., Muñoz, P., González Ramallo, V., Martínez Sellés, M., Miró Meda, J.M., Pericás, J.M., Goenaga, M.Á., Ojeda Burgos, G., Rodríguez Álvarez, R., Castelo Corral, L., Gálvez-Acebal, J., Martínez Marcos, F.J., Fariñas, M.C., Fernández Sánchez, F., Noureddine, M., Rosas, G., de la Torre Lima, J., Aramendi, J., Bereciartua, E., Blanco, M.J., Blanco, R., Boado, M.V., Campaña Lázaro, M., Crespo, A., Goikoetxea, J., Iruretagoyena, J.R., Irurzun Zuazabal, J., López-Soria, L., Montejo, M., Nieto, J., Rodrigo, D., Rodríguez, D., Rodríguez, R., Vitoria, Y., Voces, R., García López, M.V., Georgieva, R.I., Ojeda, G., Rodríguez Bailón, I., Ruiz Morales, J., Cuende, A.M., Echeverría, T., Fuerte, A., Gaminde, E., Idígoras, P., Iribarren, J.A., Izaguirre Yarza, A., Kortajarena Urkola, X., Reviejo, C., Carrasco, R., Climent, V., Llamas, P., Merino, E., Plazas, J., Reus, S., Álvarez, N., Bravo-Ferrer, J.M., Castelo, L., Cuenca, J., Llinares, P., Miguez Rey, E., Rodríguez Mayo, M., Sánchez, E., Sousa Regueiro, D., Martínez, F.J., Alonso, M.D.M., Castro, B., García Rosado, D., Durán, M.D.C., Miguel Gómez, M.A., Lacalzada, J., Nassar, I., Plata Ciezar, A., Reguera Iglesias, J.M., Asensi Álvarez, V., Costas, C., de la Hera, J., Fernández Suárez, J., Iglesias Fraile, L., León Arguero, V., López Menéndez, J., Mencia Bajo, P., Morales, C., Moreno Torrico, A., Palomo, C., Paya Martínez, B., Rodríguez Esteban, Á., Rodríguez García, R., Telenti Asensio, M., Almela, M., Ambrosioni, J., Azqueta, M., Brunet, M., Bodro, M., Cartañá, R., Falces, C., Fita, G., Fuster, D., García de la Mària, C., Hernández-Meneses, M., Llopis Pérez, J., Marco, F., Miró, J.M., Moreno, A., Nicolás, D., Ninot, S., Quintana, E., Paré, C., Pereda, D., Pomar, J.L., Ramírez, J., Rovira, I., Sandoval, E., Sitges, M., Soy, D., Téllez, A., Tolosana, J.M., Vidal, B., Vila, J., Adán, I., Bermejo, J., Bouza, E., Celemín, D., Cuerpo Caballero, G., Delgado Montero, A., Fernández Cruz, A., García Mansilla, A., García Leoni, M.E., Kestler Hernández, M., Hualde, A.M., Marín, M., Martínez-Sellés, M., Menárguez, M.C., Rincón, C., Rodríguez-Abella, H., Rodríguez-Créixems, M., Pinilla, B., Pinto, Á., Valerio, M., Vázquez, P., Verde Moreno, E., Antorrena, I., Loeches, B., Martín Quirós, A., Moreno, M., Ramírez, U., Rial Bastón, V., Romero, M., Saldaña, A., Agüero Balbín, J., Amado, C., Armiñanzas Castillo, C., Arnaiz García, A., Cobo Belaustegui, M., Fariñas-Álvarez, C., Gómez Izquierdo, R., García, I., González-Rico, C., Gutiérrez-Cuadra, M., Gutiérrez Díez, J., Pajarón, M., Parra, J.A., Sarralde, A., Teira, R., Domínguez, F., García Pavía, P., González, J., Orden, B., Ramos, A., Centella, T., Hermida, J.M., Moya, J.L., Martín-Dávila, P., Navas, E., Oliva, E., del Río, A., Ruiz, S., Hidalgo Tenorio, C., Almendro Delia, M., Araji, O., Barquero, J.M., Calvo Jambrina, R., de Cueto, M., Gálvez Acebal, J., Méndez, I., Morales, I., and Matamala Adell, M.

Abstract

Purpose: The aim of this study was to analyse the characteristics of patients with IE in three groups of age and to assess the ability of age and the Charlson Comorbidity Index (CCI) to predict mortality. Methods: Prospective cohort study of all patients with IE included in the GAMES Spanish database between 2008 and 2015. Patients were stratified into three age groups

Published
2020

15. Selection criteria of solid organ donors in relation to infectious diseases: A Spanish consensus

Author

Len O, Los-Arcos I, Aguado JM, Blanes M, Bodro M, Carratalà J, Cordero E, Fariñas MC, Fernández-Ruiz M, Fortún J, Gavaldà J, López-Medrano F, López-Vélez R, Lumbreras C, Mahillo B, Marcos MÁ, Martin-Dávila P, Montejo JM, Moreno A, Muñoz P, Norman F, Pérez-Sáenz JL, Pumarola T, Sabé N, San-Juan R, Vidal E, and Domínguez-Gil B

Abstract

The immunosuppressive treatment that recipients receive from a solid organ transplantation hinders the defensive response to infection. Its transmission from the donor can cause dysfunction or loss of the graft and even death of the recipient if proper preventive measures are not established. This potential risk should be thoroughly evaluated to minimise the risk of infection transmission from donor to recipient, especially with organ transplantation from donors with infections, without increasing graft dysfunction and morbidity and mortality in the recipient. This document aims to review current knowledge about infection screening in potential donors and offer clinical and microbiological recommendations about the use of organs from donors with infection based on available scientific evidence.

Published
2020

16. Predictors of mortality in solid organ transplant recipients with bloodstream infections due to carbapenemase-producing Enterobacterales: The impact of cytomegalovirus disease and lymphopenia

Author

Perez-Nadales, E., Gutierrez-Gutierrez, B., Natera, A. M., Abdala, E., Reina Magalhaes, M., Mularoni, A., Monaco, F., Camera Pierrotti, L., Pinheiro Freire, M., Iyer, R. N., Mehta Steinke, S., Grazia Calvi, E., Tumbarello, M., Falcone, M., Fernandez-Ruiz, M., Costa-Mateo, J. M., Rana, M. M., Mara Varejao Strabelli, T., Paul, M., Carmen Farinas, M., Clemente, W. T., Roilides, E., Munoz, P., Dewispelaere, L., Loeches, B., Lowman, W., Hock Tan, B., Escudero-Sanchez, R., Bodro, M., Antonio Grossi, P., Soldani, F., Gunseren, F., Nestorova, N., Pascual, A., Martinez-Martinez, L., Aguado, J., Rodriguez-Bano, J., Torre-Cisneros, J., Wan Song, A. T., Andraus, W., Carneiro D'Albuquerque, L. A., David-Neto, E., Jota de Paula, F., Rossi, F., Ostrander, D., Avery, R., Rizzi, M., Losito, A. R., Raffaelli, F., Del Giacomo, P., Tiseo, G., Lora-Tamayo, J., San-Juan, R., Gracia-Ahufinger, I., Caston, J., Ruiz, Y. A., Altman, D. R., Campos, S. V., Bar-Sinai, N., Koppel, F., Arnaiz de las Revillas Almajano, F., Gonzalez Rico, C., Fernandez Martinez, M., Mourao, P. H. O., Neves, F. A., Ferreira, J., Pyrpasopoulou, A., Iosifidis, E., Romiopoulos, I., Minero, M. V., Sanchez-Carrillo, C., Lardo, S., Coussement, J., Dodemont, M., Jiayun, K., Martin-Davila, P., Fortun, J., Almela, M., Moreno, A., Linares, L., Gasperina, D. D., Balsamo, M. L., Rovelli, C., Concia, E., Chiesi, S., Salerno, D. N., Ogunc, D., Pilmis, B., Seminari, E. M., Carratala, J., Dominguez, A., Cordero, E., Lepe, J. A., Montejo, M., Merino de Lucas, E., Eriksson, B. M., van Delden, C., Manuel, O., Arslan, H., Kocak Tufan, Z., Kazak, E., David, M., Lease, E., Cornaglia, G., Akova, M., European Commission, Ministerio de Ciencia, Innovación y Universidades (España), Instituto de Salud Carlos III, and Universidad de Cantabria

Subjects
medicine.medical_specialty, Combination therapy, infectious disease, 030230 surgery, Settore MED/17 - MALATTIE INFETTIVE, Logistic regression, clinical research/practice, 03 medical and health sciences, 0302 clinical medicine, infection and infectious agents - bacterial, Internal medicine, medicine, Immunology and Allergy, Pharmacology (medical), organ transplantation in general, Infection and infectious agents - bacterial, Transplantation, Infectious disease, Receiver operating characteristic, business.industry, Hazard ratio, Confidence interval, Organ transplantation in general, antibiotic drug resistance, Cohort, Clinical research/practice, Antibiotic drug resistance, business, Cohort study
Abstract

Treatment of carbapenemase‐producing Enterobacterales bloodstream infections in solid organ transplant recipients is challenging. The objective of this study was to develop a specific score to predict mortality in solid organ transplant recipients with carbapenemase‐producing Enterobacterales bloodstream infections. A multinational, retrospective (2004‐2016) cohort study (INCREMENT‐SOT, ClinicalTrials.gov NCT02852902) was performed. The main outcome variable was 30‐day all‐cause mortality. The INCREMENT‐SOT‐CPE score was developed using logistic regression. The global cohort included 216 patients. The final logistic regression model included the following variables: INCREMENT‐CPE mortality score ≥8 (8 points), no source control (3 points), inappropriate empirical therapy (2 points), cytomegalovirus disease (7 points), lymphopenia (4 points), and the interaction between INCREMENT‐CPE score ≥8 and CMV disease (minus 7 points). This score showed an area under the receiver operating characteristic curve of 0.82 (95% confidence interval [CI] 0.76‐0.88) and classified patients into 3 strata: 0‐7 (low mortality), 8‐11 (high mortality), and 12‐17 (very‐high mortality). We performed a stratified analysis of the effect of monotherapy vs combination therapy among 165 patients who received appropriate therapy. Monotherapy was associated with higher mortality only in the very‐high (adjusted hazard ratio [HR] 2.82, 95% CI 1.13‐7.06, P = .03) and high (HR 9.93, 95% CI 2.08‐47.40, P = .004) mortality risk strata. A score‐based algorithm is provided for therapy guidance., This work was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases [REIPI RD16/0016/0008; RD16/0016/0001, RD16/0016/0002, RD16/0016/00010] ‐ co‐financed by European Development Regional Fund “A way to achieve Europe”, Operative program Intelligent Growth 2014‐2020; ESCMID Study Group for Infections in Compromised Hosts [ESGICH grant to JMA]; Sociedad Andaluza de Trasplante de Órgano Sólido [SATOT grant to LMM]; ESCMID Study Group for Bloodstream Infections and Sepsis (ESGBIS); and ESCMID Study Group for Antimicrobial Resistance Surveillance (ESGARS).

Published
2020

17. Predictors of mortality in solid organ transplant recipients with bloodstream infections due to carbapenemase-producing Enterobacterales: The impact of cytomegalovirus disease and lymphopenia

Author

Perez-Nadales E, Gutierrez-Gutierrez B, Natera A, Abdala E, Magalhaes M, Mularoni A, Monaco F, Pierrotti L, Freire M, Iyer R, Steinke S, Calvi E, Tumbarello M, Falcone M, Fernandez-Ruiz M, Costa-Mateo J, Rana M, Strabelli T, Paul M, Farinas M, Clemente W, Roilides E, Munoz P, Dewispelaere L, Loeches B, Lowman W, Tan B, Escudero-Sanchez R, Bodro M, Grossi P, Soldani F, Gunseren F, Nestorova N, Pascual A, Martinez-Martinez L, Aguado J, Rodriguez-Bano J, Torre-Cisneros J, Song A, Andraus W, D'Albuquerque L, David-Neto E, de Paula F, Rossi F, Ostrander D, Avery R, Rizzi M, Losito A, Raffaelli F, Del Giacomo P, Tiseo G, Lora-Tamayo J, San-Juan R, Gracia-Ahufinger I, Caston J, Ruiz Y, Altman D, Campos S, Bar-Sinai N, Koppel F, Almajano F, Rico C, Martinez M, Mourao P, Neves F, Ferreira J, Pyrpasopoulou A, Iosifidis E, Romiopoulos I, Minero M, Sanchez-Carrillo C, Lardo S, Coussement J, Dodemont M, Jiayun K, Martin-Davila P, Fortun J, Almela M, Moreno A, Linares L, Gasperina D, Balsamo M, Rovelli C, Concia E, Chiesi S, Salerno D, Ogunc D, Pilmis B, Seminari E, Carratala J, Dominguez A, Cordero E, Lepe J, Montejo M, de Lucas E, Eriksson B, van Delden C, Manuel O, Arslan H, Tufan Z, Kazak E, David M, Lease E, Cornaglia G, Akova M, REIPI INCREMENT-SOT Investigators, Swiss Transplant Cohort Study, and ESGARS-ESCMID Study Grp Antimicrob

Subjects
infection and infectious agents - bacterial, clinical research, infectious disease, antibiotic drug resistance, organ transplantation in general, practice
Abstract

Treatment of carbapenemase-producing Enterobacterales bloodstream infections in solid organ transplant recipients is challenging. The objective of this study was to develop a specific score to predict mortality in solid organ transplant recipients with carbapenemase-producing Enterobacterales bloodstream infections. A multinational, retrospective (2004-2016) cohort study (INCREMENT-SOT, ClinicalTrials.gov NCT02852902) was performed. The main outcome variable was 30-day all-cause mortality. The INCREMENT-SOT-CPE score was developed using logistic regression. The global cohort included 216 patients. The final logistic regression model included the following variables: INCREMENT-CPE mortality score >= 8 (8 points), no source control (3 points), inappropriate empirical therapy (2 points), cytomegalovirus disease (7 points), lymphopenia (4 points), and the interaction between INCREMENT-CPE score >= 8 and CMV disease (minus 7 points). This score showed an area under the receiver operating characteristic curve of 0.82 (95% confidence interval [CI] 0.76-0.88) and classified patients into 3 strata: 0-7 (low mortality), 8-11 (high mortality), and 12-17 (very-high mortality). We performed a stratified analysis of the effect of monotherapy vs combination therapy among 165 patients who received appropriate therapy. Monotherapy was associated with higher mortality only in the very-high (adjusted hazard ratio [HR] 2.82, 95% CI 1.13-7.06, P = .03) and high (HR 9.93, 95% CI 2.08-47.40, P = .004) mortality risk strata. A score-based algorithm is provided for therapy guidance.

Published
2020

22. Mitral valve repair in infective endocarditis is not inferior to valve replacement: results from a Spanish nationwide prospective registry

Author

Cuerpo G, Valerio M, Pedraz A, Rodriguez-Abella H, Mestres C, Obrador E, Gonzalez-Calle A, Alvarez R, Garcia P, Bouza E, Sanchez F, Noureddine M, Rosas G, Lima J, Aramendi J, Bereciartua E, Blanco M, Blanco R, Boado M, Lazaro M, Crespo A, Goikoetxea J, Iruretagoyena J, Zuazabal J, Lopez-Soria L, Montejo M, Nieto J, Rodrigo D, Rodriguez D, Rodriguez R, Vitoria Y, Voces R, Lopez M, Georgieva R, Ojeda G, Bailon I, Morales J, Cuende A, Echeverria T, Fuerte A, Gaminde E, Goenaga M, Idigoras P, Iribarren J, Yarza A, Urkola X, Reviejo C, Carrasco R, Climent V, Llamas P, Merino E, Plazas J, Reus S, Alvarez N, Bravo-Ferrer J, Castelo L, Cuenca J, Llinares P, Rey E, Mayo M, Sanchez E, Regueiro D, Martinez F, Alonso M, Castro B, Rosado D, Duran M, Gomez M, Lacalzada J, Nassar I, Ciezar A, Iglesias J, Alvarez V, Costas C, de la Hera J, Suarez J, Fraile L, Arguero V, Menendez J, Bajo P, Morales C, Torrico A, Palomo C, Martinez B, Esteban A, Garcia R, Asensio M, Almela M, Ambrosioni J, Azqueta M, Brunet M, Bodro M, Cartana R, Falces C, Fita G, Fuster D, de la Maria C, Hernandez-Meneses M, Perez J, Marco F, Miro J, Moreno A, Nicolas D, Ninot S, Quintana E, Pare C, Pereda D, Pericas J, Pomar J, Ramirez J, Rovira I, Sandoval E, Sitges M, Soy D, Tellez A, Tolosana J, Vidal B, Vila J, Adan I, Bermejo J, Celemin D, Caballero G, Pinto A, Montero A, Cruz A, Mansilla A, Leoni M, Ramallo V, Hernandez M, Hualde A, Marin M, Martinez-Selles M, Menarguez M, Munoz P, Rincon C, Rodriguez-Creixems M, Pinilla B, Vazquez P, Moreno E, Antorrena I, Loeches B, Quiros A, Moreno M, Ramirez U, Baston V, Romero M, Saldana A, Balbin J, Castillo C, Arnaiz A, Revillas F, Belaustegui M, Farinas M, Farinas-Alvarez C, Izquierdo R, Garcia I, Rico C, Gutierrez-Cuadra M, Diez J, Pajaron M, Parra J, Teira R, Zarauza J, Dominguez F, Pavia P, Gonzalez J, Orden B, Ramos A, Centella T, Hermida J, Moya J, Martin-Davila P, Navas E, Oliva E, del Rio A, Ruiz S, Tenorio C, Delia M, Araji O, Barquero J, Jambrina R, de Cueto M, Acebal J, Mendez I, Morales I, Lopez-Cortes L, de Alarcon A, Garcia E, Haro J, Lepe J, Lopez F, Luque R, Alonso L, Azcarate P, Gutierrez J, Blanco J, Villegas A, Garcia-Alvarez L, Oteo J, Sanz M, de Benito N, Gurgui M, Pacho C, Pericas R, Pons G, Alvarez M, Fernandez A, Martinez A, Prieto A, Regueiro B, Tijeira E, Vega M, Blasco A, Mollar J, Arana J, Uriarte O, Lopez A, de Zarate Z, Matos J, Dominguez G, Sanchez-Porto A, Leal J, Vazquez E, Torres A, Blazquez A, Valenzuela G, Alonso A, Aramburu J, Calvo F, Rodriguez A, Tarabini-Castellani P, Galvez E, Bellido C, Pau J, Sepulveda M, Sierra P, Iqbal-Mirza S, Alcolea E, Yanez I, Ballesta A, Escobar E, Monje A, Cabrera V, Garcia D, Asenjo M, Luna C, Morcillo J, Seco M, Gelabert A, Guallar C, Abad N, Mangas P, Adell M, Ruiz M, Porres J, Trigueros N, Espin M, Caro J, Sanchez R, Almazan A, Freire A, Gonzalez M, Ramis P, Bordes E, Bonet L, Munera M, Garaizabal E, Luque J, and GAMEs Study Grp

Subjects
Infectious endocarditis, Mitral valve reparation, Cardiac surgery, Mitral valve replacement
Abstract

IntroductionInfective endocarditis (IE) still carries high morbidity and mortality and frequently requires surgery. The benefit of mitral valve repair (MVr) in the setting of IE is yet to be proven. The goal of this study was to assess the results of MVr in patients with IE after a minimum follow-up of 1year.MethodsThis study is based on a Spanish nationwide prospective registry that included patients operated on for native mitral valve IE. The collaborating Institutions pooled their pre-, peri-, and postoperative data into the database of the GAMES group [Grupo de Apoyo al Manejo de la EndocarditiS (Group for support and management of infective endocarditis)].ResultsData from 27 hospitals were recorded and 3524 cases of active IE identified between 2008 and 2016. There were 1513 cases of mitral IE, of which 898 involved native valves. Of these, 437 patients underwent surgical treatment, and 369 completed the 1-year follow-up. The valve was repaired in 68 cases (18.4%). Preoperative groups were comparable (EuroSCORE MVr 7.7 vs MVR 8.0; p=ns). Mortality in the repair group was inferior to that in the replacement group (16.2% vs 27.2%, p=0.058). At 1year, mortality remained higher in the replacement group: 3.7% vs 2.9%. Relapse of the infection was slightly more frequent in the repair group (7.1% vs 3.7%; p=ns), although this did not lead to higher rates of reintervention (MVr/MVR: 2.9% vs 4.9%).ConclusionMVr is an attractive option for specific patients with IE and does not seem to negatively impact on relapses.

Published
2019

23. Outpatient Parenteral Antibiotic Treatment for Infective Endocarditis: A Prospective Cohort Study From the GAMES Cohort

Author

Llopis J, Gonzalez-Ramallo V, Goenaga M, Garcia-Leoni M, Farinas M, Oteo J, Carrizo E, Reguera-Iglesias J, Hidalgo-Tenorio C, Sanchez F, Noureddine M, Rosas G, Lima J, Blanco R, Boado M, Lazaro M, Crespo A, Goikoetxea J, Iruretagoyena J, Zuazabal J, Lopez-Soria L, Montejo M, Nieto J, Rodrigo D, Rodriguez R, Vitoria Y, Voces R, Lopez M, Georgieva R, Ojeda G, Bailon I, Morales J, Cuende A, Echeverria T, Fuerte A, Gaminde E, Idigoras P, Iribarren J, Yarza A, Urkola X, Reviejo C, Carrasco R, Climent V, Llamas P, Merino E, Plazas J, Reus S, Alvarez N, Bravo-Ferrer J, Castelo L, Cuenca J, Llinares P, Rey E, Mayo M, Sanchez E, Regueiro D, Martinez F, Alonso M, Castro B, Rosado D, Duran M, Gomez M, Lacalzada J, Nassar I, Ciezar A, Iglesias J, Alvarez V, Costas C, de la Hera J, Suarez J, Fraile L, Arguero V, Menendez J, Bajo P, Morales C, Torrico A, Palomo C, Martinez B, Esteban A, Garcia R, Asensio M, Almela M, Ambrosioni J, Azqueta M, Brunet M, Bodro M, Cartana R, Falces C, Fita G, Fuster D, de la Maria C, Garcia-Valls L, Hernandez-Meneses M, Perez J, Marco F, Miro J, Moreno A, Nicolas D, Ninot S, Quintana E, Pare C, Pereda D, Pericas J, Pomar J, Ramirez J, Rovira I, Sandoval E, Sala M, Sitges M, Soy D, Tellez A, Tolosana J, Vidal B, Vila J, Adan I, Bermejo J, Bouza E, Celemin D, Caballero G, Montero A, Cruz A, Mansilla A, Leoni M, Ramallo V, Hernandez M, Hualde A, Marin M, Martinez-Selles M, Menarguez M, Munoz P, Rincon C, Rodriguez-Abella H, Rodriguez-Creixems M, Pinilla B, Pinto A, Valerio M, Vazquez P, Moreno E, Antorrena I, Loeches B, Quiros A, Moreno M, Ramirez U, Baston V, Romero M, Saldana A, Balbin J, Castillo C, Arnaiz A, Revillas F, Belaustegui M, Farinas-Alvarez C, Izquierdo R, Garcia I, Rico C, Gutierrez-Cuadra M, Diez J, Pajaron M, Parra J, Teira R, Zarauza J, Dominguez F, Pavia P, Gonzalez J, Orden B, Ramos A, Centella T, Hermida J, Moya J, Martin-Davila P, Navas E, Oliva E, del Rio A, Stuart J, Rodriguez S, Tenorio C, Delia M, Araji O, Barquero J, Jambrina R, de Cueto M, Acebal J, Mendez I, Morales I, Lopez-Cortes L, de Alarcon A, Garcia E, Haro J, Lepe J, Lopez F, Luque R, Alonso L, Azcarate P, Gutierrez J, Blanco J, Garcia-Alvarez L, Sanz M, de Benito N, Gurgui M, Pacho C, Pericas R, Pons G, Alvarez M, Fernandez A, Martinez A, Prieto A, Regueiro B, Tijeira E, Vega M, Blasco A, Mollar J, Arana J, Uriarte O, Lopez A, de Zarate Z, Matos J, Dominguez G, Sanchez-Porto A, Leal J, Vazquez E, Torres A, Blazquez A, Valenzuela G, Alonso A, Aramburu J, Calvo F, Rodriguez A, Tarabini-Castellani P, Galvez E, Bellido C, Pau J, Sepulveda M, Sierra P, Iqbal-Mirza S, Alcolea E, Serrano P, Roca J, Yanez I, Ballesta A, Soriano V, Escobar E, Monje A, Cabrera V, Garcia D, Asenjo M, Luna C, Morcillo J, Seco M, Gelabert A, Guallar C, Abad N, Mangas P, Adell M, Ruiz M, Porres J, Trigueros N, Espin M, Caro J, Sanchez R, Almazan A, Freire A, Gonzalez M, Ramis P, Blanco M, Bordes E, Bonet L, Munera M, Garaizabal E, Luque J, and Spanish Collaboration Endocarditis

Subjects
infective endocarditis, readmission, outpatient parenteral antibiotic treatment, outcomes, hospitalization
Abstract

Background. Outpatient parenteral antibiotic treatment (OPAT) has proven efficacious for treating infective endocarditis (IE). However, the 2001 Infectious Diseases Society of America (IDSA) criteria for OPAT in IE are very restrictive. We aimed to compare the outcomes of OPAT with those of hospital-based antibiotic treatment (HBAT). Methods. Retrospective analysis of data from a multicenter, prospective cohort study of 2000 consecutive IE patients in 25 Spanish hospitals (2008-2012) was performed. Results. A total of 429 patients (21.5%) received OPAT, and only 21.7% fulfilled IDSA criteria. Males accounted for 70.5%, median age was 68 years (interquartile range [IQR], 56-76), and 57% had native-valve IE. The most frequent causal microorganisms were viridans group streptococci (18.6%), Staphylococcus aureus (15.6%), and coagulase-negative staphylococci (14.5%). Median length of antibiotic treatment was 42 days (IQR, 32-54), and 44% of patients underwent cardiac surgery. One-year mortality was 8% (42% for HBAT; P < .001), 1.4% of patients relapsed, and 10.9% were readmitted during the first 3 months after discharge (no significant differences compared with HBAT). Charlson score (odds ratio [OR], 1.21; 95% confidence interval [CI], 1.04-1.42; P = .01) and cardiac surgery (OR, 0.24; 95% CI, .09-.63; P = .04) were associated with 1-year mortality, whereas aortic valve involvement (OR, 0.47; 95% CI, .22-.98; P = .007) was the only predictor of 1-year readmission. Failing to fulfill IDSA criteria was not a risk factor for mortality or readmission. Conclusions. OPAT provided excellent results despite the use of broader criteria than those recommended by IDSA. OPAT criteria should therefore be expanded.

Published
2019

24. Effect of the type of surgical indication on mortality in patients with infective endocarditis who are rejected for surgical intervention

Author

Ramos-Martinez A, Calderon-Parra J, Miro J, Farinas M, Goenaga M, Marcos F, Vinuesa D, Sanchez F, Noureddine M, Rosas G, Lima J, Aramendi J, Blanco M, Blanco R, Boado M, Lazaro M, Crespo A, Goikoetxea J, Iruretagoyena J, Zuazabal J, Lopez-Soria L, Montejo M, Nieto J, Rodrigo D, Rodriguez D, Rodriguez R, Vitoria Y, Voces R, Lopez M, Georgieva R, Ojeda G, Bailon I, Morales J, Cuende A, Echeverria T, Fuerte A, Gaminde E, Idigoras P, Iribarren J, Yarza A, Urkola X, Reviejo C, Carrasco R, Climent V, Llamas P, Merino E, Plazas J, Reus S, Alvarez N, Bravo-Ferrer J, Castelo L, Cuenca J, Llinares P, Rey E, Mayo M, Sanchez E, Regueiro D, Martinez F, Alonso M, Castro B, Rosado D, Duran M, Gomez M, Lacalzada J, Nassar I, Ciezar A, Iglesias J, Alvarez V, Costas C, de la Hera J, Suarez J, Fraile L, Arguero V, Menendez J, Bajo P, Morales C, Torrico A, Palomo C, Martinez B, Esteban A, Garcia R, Asensio M, Almela M, Ambrosioni J, Azqueta M, Brunet M, Bodro M, Cartana R, Falces C, Fita G, Fuster D, de la Maria C, Hernandez-Meneses M, Perez J, Marco F, Moreno A, Nicolas D, Ninot S, Quintana E, Pare C, Pereda D, Pericas J, Pomar J, Ramirez J, Rovira I, Sandoval E, Sitges M, Soy D, Tellez A, Tolosana J, Vidal B, Vila J, Adan I, Bermejo J, Bouza E, Celemin D, Caballero G, Montero A, Cruz A, Mansilla A, Leoni M, Ramallo V, Hernandez M, Hualde A, Marin M, Martinez-Selles M, Menarguez M, Munoz P, Rincon C, Rodriguez-Abella H, Rodriguez-Creixems M, Pinilla B, Pinto A, Valerio M, Vazquez P, Moreno E, Antorrena I, Loeches B, Quiros A, Moreno M, Ramirez U, Baston V, Romero M, Saldana A, Balbin J, Castillo C, Arnaiz A, de las Revillas F, Belaustegui M, Farinas-Alvarez C, Izquierdo R, Garcia I, Rico C, Gutierrez-Cuadra M, Diez J, Pajaron M, Parra J, Teira R, Zarauza J, Dominguez F, Pavia P, Gonzalez J, Orden B, Ramos A, Centella T, Hermida J, Moya J, Martin-Davila P, Navas E, Oliva E, del Rio A, Ruiz S, Tenorio C, Delia M, Araji O, Barquero J, Jambrina R, de Cueto M, Acebal J, Mendez I, Morales I, Lopez-Cortes L, de Alarcon A, Garcia E, Haro J, Lepe J, Lopez F, Luque R, Alonso L, Azcarate P, Gutierrez J, Blanco J, Villegas A, Garcia-Alvarez L, Oteo J, Sanz M, de Benito N, Gurgui M, Pacho C, Pericas R, Pons G, Alvarez M, Fernandez A, Martinez A, Prieto A, Regueiro B, Tijeira E, Vega M, Blasco A, Mollar J, Arana J, Uriarte O, Lopez A, de Zarate Z, Matos J, Gloria G, Antonio S, Leal J, Vazquez E, Torres A, Blazquez A, Valenzuela G, Alonso A, Aramburu J, Calvo F, Rodriguez A, Tarabini-Castellani P, Galvez E, Bellido C, Pau J, Sepulveda M, Sierra P, Iqbal-Mirza S, Alcolea E, Yanez I, Ballesta A, Escobar E, Monje A, Cabrera V, Garcia D, Asenjo M, Luna C, Morcillo J, Seco M, Villoslada A, Guallar A, Abad N, Mangas P, Adell M, Ruiz M, Porres J, Trigueros N, Espin M, Caro J, Sanchez R, Almazan A, Freire A, Gonzalez M, Ramis P, Bordes E, Bonet L, Munera M, Garaizabal E, Luque J, and Spanish Collaboration Endocarditis

Subjects
Endocarditis, Embolism, Heart failure, Bacteremia, Mortality
Abstract

Aim: To evaluate the effect of the type of surgical indication on mortality in infective endocarditis (IE) patients who are rejected for surgery. Methods and results: From January 2008 to December 2016, 2714 patients with definite left-sided IE were attended in the participating hospitals. One thousand six hundred and fifty-three patients (60.9%) presented surgical indications. Five hundred and thirty-eight patients (32.5%) presented surgical indications but received medical treatment alone. The indications for surgery in these patients were uncontrolled infection (366 patients, 68%), heart failure (168 patients, 31.3%) and prevention of embolism (148 patients, 27.6%). One hundred and thirty patients (24.2%) presented more than one indication. The mortality during hospital admission was 60% (323 patients). The in-hospital mortality of patients whose indication for surgery was heart failure, uncontrolled infection or risk of embolism was 75.6%, 61.4% and 54.7%, respectively (p < 0.001). Surgical indications due to heart failure (OR: 3.24; CI 95%: 1.99-5.9) or uncontrolled infection (OR: 1.83; CI 95%: 1.04-3.18) were independently associated with a fatal outcome during hospital admission. Mortality during the first year was 75.4%. The mortality during the first year in patients whose indication for surgery was heart failure, uncontrolled infection or risk of embolism was 85.9%, 76.7% and 72.7%, respectively (p = 0.016). Surgical indication due to heart failure (OR: 3.03; CI 95%: 1.53-5.98) were independently associated with fatal outcome during the first year. Conclusions: The type of surgical indication is associated with mortality in IE patients who are rejected for surgical intervention. (c) 2019 Elsevier B.V. All rights reserved.

Published
2019

25. The Impact of Culturing the Organ Preservation Fluid on Solid Organ Transplantation : A Prospective Multicenter Cohort Study

Author

Oriol, I, Sabe, N, Càmara, J, Berbel, D, Ballesteros, M A, Escudero, R, Lopez-Medrano, F, Linares, L, Len, O, Silva, J T, Oliver, E, Soldevila, L, Pérez-Recio, S, Guillem, L L, Camprubí, D, LLadó, L, Manonelles, A, González-Costello, J, Domínguez, M A, Fariñas, M C, Lavid, N, González-Rico, C, Garcia-Cuello, L, Arnaiz de las Revillas, F, Fortun, J, Aguado, José María, Jimenez-Romero, C, Bodro, M, Almela, M, Paredes, D, Moreno Camacho, Asunción, Pérez-Cameo, C, Muñoz-Sanz, A, Blanco-Fernández, G, Cabo-González, J A, García-López, J L, Nuño, E, Carratalà, J, Oriol, I, Sabe, N, Càmara, J, Berbel, D, Ballesteros, M A, Escudero, R, Lopez-Medrano, F, Linares, L, Len, O, Silva, J T, Oliver, E, Soldevila, L, Pérez-Recio, S, Guillem, L L, Camprubí, D, LLadó, L, Manonelles, A, González-Costello, J, Domínguez, M A, Fariñas, M C, Lavid, N, González-Rico, C, Garcia-Cuello, L, Arnaiz de las Revillas, F, Fortun, J, Aguado, José María, Jimenez-Romero, C, Bodro, M, Almela, M, Paredes, D, Moreno Camacho, Asunción, Pérez-Cameo, C, Muñoz-Sanz, A, Blanco-Fernández, G, Cabo-González, J A, García-López, J L, Nuño, E, and Carratalà, J

Abstract

We analyzed the prevalence, etiology, and risk factors of culture-positive preservation fluid and their impact on the management of solid organ transplant recipients. From July 2015 to March 2017, 622 episodes of adult solid organ transplants at 7 university hospitals in Spain were prospectively included in the study. The prevalence of culture-positive preservation fluid was 62.5% (389/622). Nevertheless, in only 25.2% (98/389) of the cases were the isolates considered "high risk" for pathogenicity. After applying a multivariate regression analysis, advanced donor age was the main associated factor for having culture-positive preservation fluid for high-risk microorganisms. Preemptive antibiotic therapy was given to 19.8% (77/389) of the cases. The incidence rate of preservation fluid-related infection was 1.3% (5 recipients); none of these patients had received preemptive therapy. Solid organ transplant (SOT) recipients with high-risk culture-positive preservation fluid receiving preemptive antibiotic therapy presented both a lower cumulative incidence of infection and a lower rate of acute rejection and graft loss compared with those who did not have high-risk culture-positive preservation fluid. After adjusting for age, sex, type of transplant, and prior graft rejection, preemptive antibiotic therapy remained a significant protective factor for 90-day infection. The routine culture of preservation fluid may be considered a tool that provides information about the contamination of the transplanted organ. Preemptive therapy for SOT recipients with high-risk culture-positive preservation fluid may be useful to avoid preservation fluid-related infections and improve the outcomes of infection, graft loss, and graft rejection in transplant patients.

Published
2019

26. The Impact of Culturing the Organ Preservation Fluid on Solid Organ Transplantation: A Prospective Multicenter Cohort Study

Author

Oriol, I, primary, Sabe, N, additional, Càmara, J, additional, Berbel, D, additional, Ballesteros, M A, additional, Escudero, R, additional, Lopez-Medrano, F, additional, Linares, L, additional, Len, O, additional, Silva, J T, additional, Oliver, E, additional, Soldevila, L, additional, Pérez-Recio, S, additional, Guillem, L L, additional, Camprubí, D, additional, LLadó, L, additional, Manonelles, A, additional, González-Costello, J, additional, Domínguez, M A, additional, Fariñas, M C, additional, Lavid, N, additional, González-Rico, C, additional, Garcia-Cuello, L, additional, Arnaiz de las Revillas, F, additional, Fortun, J, additional, Aguado, J M, additional, Jimenez-Romero, C, additional, Bodro, M, additional, Almela, M, additional, Paredes, D, additional, Moreno, A, additional, Pérez-Cameo, C, additional, Muñoz-Sanz, A, additional, Blanco-Fernández, G, additional, Cabo-González, J A, additional, García-López, J L, additional, Nuño, E, additional, and Carratalà, J, additional

Published
2019
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28. Network meta‐analysis of post‐exposure prophylaxis randomized clinical trials.

Author

Fernández, I, Lazzari, E., Inciarte, A., Diaz‐Brito, V., Milinkovic, A., Arenas‐Pinto, A., Etcheverrry, F., García, F., Leal, L, Fernandez, E, Gonzalez, E, Lucero, C, Leon, A, Garcıa, F, Manzardo, C, Nicolas, D, Bodro, M, del Rıo, A, Cardozo, C, and Cervera, C

Subjects
HIV prevention, MEDLINE, META-analysis, ONLINE information services, SYSTEMATIC reviews, ANTIRETROVIRAL agents, RANDOMIZED controlled trials, TREATMENT effectiveness, MEN who have sex with men, ATAZANAVIR, LOPINAVIR-ritonavir, MARAVIROC (Drug), RALTEGRAVIR, HIV integrase inhibitors
Abstract

Objectives: We performed a network meta‐analysis of PEP randomized clinical trials to evaluate the best regimen. Methods: After MEDLINE/Pubmed search, studies were included if: (1) were randomized, (2) comparing at least 2 PEP three‐drug regimens and, (3) reported completion rates or discontinuation at 28 days. Five studies with 1105 PEP initiations were included and compared ritonavir‐boosted lopinavir (LPV/r) vs. atazanavir (ATV) (one study), cobicistat‐boosted elvitegravir (EVG/c) (one study), raltegravir (RAL) (one study) or maraviroc (MVC) (two studies). We estimated the probability of each treatment of being the best based on the evaluation of five outcomes: PEP non‐completion at day 28, PEP discontinuation due to adverse events, PEP switching due to any cause, lost to follow‐up and adverse events. Results: Participants were mostly men who have sex with men (n = 832, 75%) with non‐occupational exposure to HIV (89.86%). Four‐hundred fifty‐four (41%) participants failed to complete their PEP course for any reason. The Odds Ratio (OR) for PEP non‐completion at day 28 in each antiretroviral compared to LPV/r was: ATV 0.95 (95% CI 0.58–1.56; EVG/c: OR 0.65 95% CI 0.30–1.37; RAL: OR 0.68 95% CI 0.41–1.13; and MVC: OR 0.69 95% CI 0.47–1.01. In addition, the rankogram showed that EVG/c had the highest probability of being the best treatment for the lowest rates in PEP non‐completion at day 28, switching, lost to follow‐up or adverse events and MVC for PEP discontinuations due to adverse events. Conclusions: Our study shows the advantages of integrase inhibitors when used as PEP, particularly EVG as a Single‐Tablet Regimen. [ABSTRACT FROM AUTHOR]

Published
2021
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29. Post‐exposure prophylaxis for HIV infection in sexual assault victims.

Author

Inciarte, A, Leal, L, Masfarre, L, Gonzalez, E, Diaz‐Brito, V, Lucero, C, Garcia‐Pindado, J, León, A, García, F, Manzardo, C., Nicolás, D., Bodro, M., Río, A., Cardozo, C., Cervera, C., Pericás, J. M., Sanclemente, G., García‐Pindado, J., Cobos, N., and Calle, C.

Subjects
DIAGNOSIS of HIV infections, HIV prevention, GASTROINTESTINAL diseases, HEALTH facilities, PATIENT aftercare, HOSPITAL emergency services, OUTPATIENT services in hospitals, LONGITUDINAL method, SCIENTIFIC observation, PATIENT compliance, RISK assessment, SEX crimes, VICTIMS, ANTIRETROVIRAL agents, TERMINATION of treatment, TREATMENT effectiveness, RETROSPECTIVE studies, MEN who have sex with men, AIDS serodiagnosis, DISEASE risk factors
Abstract

Objectives: Sexual assault (SA) is recognized as a public health problem of epidemic proportions. Guidelines recommend the administration of post‐exposure prophylaxis (PEP) after an SA. However, few data are available about the feasibility of this strategy, and this study was conducted to assess this. Methods: We conducted a retrospective, longitudinal, observational study in SA victims attending the Hospital Clinic in Barcelona from 2006 to 2015. A total of 1695 SA victims attended the emergency room (ER), of whom 883 met the PEP criteria. Five follow‐up visits were scheduled at days 1, 10, 28, 90 and 180 in the out‐patient clinic. The primary endpoint was PEP completion rate at day 28. Secondary endpoints were loss to follow‐up, treatment discontinuation, occurrence of adverse events (AEs) and rate of seroconversion. Results: The median age of participants was 25 years [interquartile range (IQR) 21–33 years] and 93% were female. The median interval between exposure and presentation at the ER was 13 h (IQR 6–24 h). The level of risk was appreciable in 47% (n = 466) of individuals. Of 883 patients receiving PEP, 631 lived in Catalonia. In this group, the PEP completion rate at day 28 was 29% (n = 183). The follow‐up rate was 63% (n = 400) and 38% (n = 241) at days 1 and 28, respectively. Treatment discontinuation was present in 58 (15%) of 400 patients who attended at least the day 1 visit, the main reason being AEs (n = 35; 60%). AEs were reported in 226 (56%) patients, and were mainly gastrointestinal (n = 196; 49%). Only 211 (33%) patients returned for HIV testing at day 90. A single seroconversion was observed in a men who have sex with men (MSM) patient at day 120. Conclusions: Follow‐up and compliance rates in SA victims were poor. In addition, > 50% of the patients experienced AEs, which were the main reason for PEP interruption. Strategies to increase follow‐up testing and new better tolerated drug regimens must be investigated to address these issues. [ABSTRACT FROM AUTHOR]

Published
2020
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31. Risk Factors, Clinical Features, and Outcomes of Toxoplasmosis in Solid-Organ Transplant Recipients: A Matched Case-Control Study

Author

Fernàndez-Sabé N, Cervera C, Fariñas MC, Bodro M, Muñoz P, Gurguí M, Torre-Cisneros J, Martín-Dávila P, Noblejas A, Len O, García-Reyne A, Del Pozo JL, and Carratalà J

Subjects
Adult, Male, Microbiology (medical), Adolescent, Organ Transplantation, Middle Aged, Young Adult, Infectious Diseases, Anti-Infective Agents, Risk Factors, Case-Control Studies, Humans, Prednisone, Female, Toxoplasmosis, Aged
Abstract

Background. Solid-organ transplant (SOT) recipients are considered to be at increased risk for toxoplasmosis. However, risk factors for this infection have not been assessed. The aim of this study was to determine the risk factors, clinical features, and outcomes of toxoplasmosis in SOT recipients. Methods. A multicenter, matched case-control study (1:2 ratio) was conducted between 2000 and 2009. Control subjects were matched for center, transplant type, and timing. Cases were identified from the hospitals' microbiology and transplantation program databases. Logistic regression was performed to identify independent risk factors. Results. Twenty-two cases (0.14%) of toxoplasmosis were identified among 15 800 SOTs performed in 11 Spanish hospitals, including 12 heart, 6 kidney, and 4 liver recipients. Diagnosis was made by seroconversion (n = 17), histopathologic examination (n = 5), polymerase chain reaction (n = 2), and autopsy (n = 2). In a comparison of case patients with 44 matched control subjects, a negative serostatus prior to transplantation was the only independent risk factor for toxoplasmosis (odds ratio, 15.12 [95% confidence interval, 2.37-96.31]; P 5.004). The median time to diagnosis following transplantation was 92 days. Primary infection occurred in 18 (81.8%) cases. Manifestations included pneumonitis (n = 7), myocarditis (n = 5), brain abscesses (n = 5), chorioretinitis (n = 3), lymph node enlargement (n = 2), hepatosplenomegaly (n = 2), and meningitis (n =1). Five patients (22.7%) had disseminated disease. Crude mortality rate was 13.6% (3 of 22 patients). Conclusions. Although uncommon, toxoplasmosis in SOT patients causes substantial morbidity and mortality. Seronegative recipients are at high risk for developing toxoplasmosis and should be given prophylaxis and receive careful follow-up.

Published
2011

35. Influenza vaccination during the first 6 months after solid organ transplantation is efficacious and safe

Author

Pérez-Romero, P., primary, Bulnes-Ramos, A., additional, Torre-Cisneros, J., additional, Gavaldá, J., additional, Aydillo, T.A., additional, Moreno, A., additional, Montejo, M., additional, Fariñas, M.C., additional, Carratalá, J., additional, Muñoz, P., additional, Blanes, M., additional, Fortún, J., additional, Suárez-Benjumea, A., additional, López-Medrano, F., additional, Barranco, J.L., additional, Peghin, M., additional, Roca, C., additional, Lara, R., additional, Cordero, E., additional, Alamo, J.M., additional, Gasch, A., additional, Gentil-Govantes, M.A., additional, Molina-Ortega, F.J., additional, Lage, E., additional, Martínez-Atienza, J., additional, Sánchez, M., additional, Rosso, C., additional, Arizón, J.M., additional, Aguera, M., additional, Cantisán, S., additional, Montero, J.L., additional, Páez, A., additional, Rodríguez, A., additional, Santos, S., additional, Vidal, E., additional, Berasategui, C., additional, Campins, M., additional, López-Meseguer, M., additional, Saez, B., additional, Marcos, M.A., additional, Sanclemente, G., additional, Diez, N., additional, Goikoetxea, J., additional, Casafont, F., additional, Cobo-Beláustegy, M., additional, Durán, R., additional, Fábrega-García, E., additional, Fernández-Rozas, S., additional, González-Rico, C., additional, Zurbano-Goñi, F., additional, Bodro, M., additional, Niubó, J., additional, Oriol, S., additional, Sabé, N., additional, Anaya, F., additional, Bouza, E., additional, Catalán, P., additional, Diez, P., additional, Eworo, A., additional, Kestler, M., additional, Lopez-Roa, P., additional, Rincón, D., additional, Rodríguez, M., additional, Salcedo, M., additional, Sousa, Y., additional, Valerio, M., additional, Morales-Barroso, I., additional, Aguado, J.M., additional, and Origuen, J., additional

Published
2015
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36. Regional differences in the management and outcome of kidney transplantation in patients with human immunodeficiency virus infection: A 3-year retrospective cohort study.

Author

Cristelli, Marina P., Cofán, Federico, Tedesco‐Silva, Helio, Trullàs, Joan Carles, Santos, Daniel Wagner C. L., Manzardo, Christian, Agüero, Fernando, Moreno, Asunción, Oppenheimer, Federico, Diekmann, Fritz, Medina‐Pestana, Jose O., Miro, Jose Maria, Alcaraz, A., Ambrosioni, J., Bodro, M., Blanco, J.L., Brunet, M., Garcia, F., Paredes, D., and Esforzado, N.

Subjects
KIDNEY transplantation, HIV-positive persons, HEPATITIS C virus, BACTERIAL diseases, REGIONAL differences
Abstract

Background In the developed world, kidney transplantation ( KT) in patients with human immunodeficiency virus ( HIV) infection is well established. Developing countries concentrate 90% of the people living with HIV, but their experience is underreported. Regional differences may affect outcomes. Objectives We compared the 3-year outcomes of patients with HIV infection receiving a KT in two different countries, in terms of incomes and development. Methods This was an observational, retrospective, double-center study, including all HIV-infected patients >18 years old undergoing KT. Results Between 2005 and 2015, 54 KTs were performed (39 in a Brazilian center, and 15 in a Spanish center). Brazilians had less hepatitis C virus co-infection (5% vs 27%, P=.024). Median cold ischemia time was higher in Brazil (25 vs 18 hours, P=.001). Biopsy-proven acute rejection ( AR) was higher in Brazil (33% vs 13%, P=.187), as were the number of AR episodes (22 vs 4, P=.063). Patient survival at 3 years was 91.3% in Brazil and 100% in Spain; P=.663. All three cases of death in Brazil were a result of bacterial infections within the first year post transplant. At 3 years, survival free from immunosuppressive changes was lower in Brazil (56% vs 90.9%, P=.036). Raltegravir-based treatment to avoid interaction with calcineurin inhibitor was more prevalent in Spain (80% vs 3%; P<.001). HIV infection remained under control in all patients, with undetectable viral load and no opportunistic infections. Conclusion Important regional differences exist in the demographics and management of immunosuppression and antiretroviral therapy. These details may influence AR and infectious complications. Non- AIDS infections leading to early mortality in Brazil deserve special attention. [ABSTRACT FROM AUTHOR]

Published
2017
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43. Brain abscess due to Listeria monocytogenes after HELLP syndrome in a patient with antiphospholipid syndrome.

Author

Fervienza, A., Bodro, M., Castro, P., Hernández, S., Teixidó, I., Espinosa, G., and Cervera, R.

Subjects
*LISTERIA monocytogenes, *BRAIN abscess, *HELLP syndrome, *ANTIPHOSPHOLIPID syndrome, *PREGNANCY complications, *HISTORY of medicine
Abstract

Objective: To illustrate an unusual case of Listeria cerebral abscess. Material and methods: A 32-year-old pregnant woman with thrombotic antiphospholipid syndrome (APS) received corticotherapy for two weeks due to hemolysis, elevated liver enzymes, low platelet (HELLP) syndrome. After delivery she presented with neurological symptoms and fever. Results: The MRI scan confirmed the presence of a brain abscess, and Listeria monocytogenes was isolated in blood cultures. After eight weeks of antibiotic treatment, the patient presented no sequelae. Conclusion: L. monocytogenes should be included in the differential diagnosis of patients with fever and neurological dysfunction, especially in those with a recent history of corticotherapy. [ABSTRACT FROM AUTHOR]

Published
2017
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47. Antifungal prophylaxis with nebulized amphotericin-B in solid-organ transplant recipients with severe COVID-19: a retrospective observational study

Author

Alexander Rombauts, Marta Bodro, Victor Daniel Gumucio, Irene Carbonell, Àlex Favà, Laura Lladó, José González-Costello, Federico Oppenheimer, María Ángeles Castel-Lavilla, Oscar Len, Ester Marquez-Algaba, Xavier Nuvials-Casals, Daniel Martínez González, Judith Sacanell Lacasa, Jordi Carratalà, Nuría Sabé, Institut Català de la Salut, [Rombauts A] Department of Infectious Diseases, Hospital Universitario de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain. [Bodro M, Carbonell I] Department of Infectious Diseases, Hospital Clínic de Barcelona, Barcelona, Spain. [Daniel Gumucio V] Department of Intensive Care Medicine, Hospital Universitario de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain. [Favà À] Renal Transplant Unit, Hospital Universitario de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain. [Lladó L] Liver Transplant Unit, Hospital Universitario de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain. [Len O] Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. [Marquez-Algaba E] Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. [Nuvials-Casals X, Martínez González D, Sacanell Lacasa J] Servei de Medicina Intensiva, Vall d'Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Microbiology (medical), acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antifúngicos [COMPUESTOS QUÍMICOS Y DROGAS], Otros calificadores::/uso terapéutico [Otros calificadores], Immunology, Surgical Procedures, Operative::Transplantation::Organ Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Trasplantació d'òrgans, teixits, etc, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Medicaments antifúngics - Ús terapèutic, Microbiology, COVID-19 (Malaltia), Infectious Diseases, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antifungal Agents [CHEMICALS AND DRUGS], virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], intervenciones quirúrgicas::trasplante::trasplante de órganos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Other subheadings::/therapeutic use [Other subheadings]
Abstract

Aspergillosis; COVID-19; Prophylaxis Aspergilosis; COVID-19; Profilaxis Aspergilosi; COVID 19; Profilaxi COVID-19-associated pulmonary aspergillosis (CAPA) has emerged as a frequent complication in the intensive care unit (ICU). However, little is known about this life-threatening fungal superinfection in solid organ transplant recipients (SOTRs), including whether targeted anti-mold prophylaxis might be justified in this immunosuppressed population. We performed a multicentric observational retrospective study of all consecutive ICU-admitted COVID-19 SOTRs between August 1, 2020 and December 31, 2021. SOTRs receiving antifungal prophylaxis with nebulized amphotericin-B were compared with those without prophylaxis. CAPA was defined according the ECMM/ISHAM criteria. Sixty-four SOTRs were admitted to ICU for COVID-19 during the study period. One patient received antifungal prophylaxis with isavuconazole and was excluded from the analysis. Of the remaining 63 SOTRs, nineteen (30.2%) received anti-mold prophylaxis with nebulized amphotericin-B. Ten SOTRs who did not receive prophylaxis developed pulmonary mold infections (nine CAPA and one mucormycosis) compared with one who received nebulized amphotericin-B (22.7% vs 5.3%; risk ratio 0.23; 95%CI 0.032-1.68), but with no differences in survival. No severe adverse events related to nebulized amphotericin-B were recorded. SOTRs admitted to ICU with COVID-19 are at high risk for CAPA. However, nebulized amphotericin-B is safe and might reduce the incidence of CAPA in this high-risk population. A randomized clinical trial to confirm these findings is warranted. AR received a predoctoral research grant from the Instituto de Salud Carlos III, Spanish Ministry of Science, Innovation and Universities, (PFIS grant FI18/00183). This work was supported by the Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía, Industria y Competitividad, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain. We thank CERCA Programme/Generalitat de Catalunya for institutional support.

Published
2023

48. Isavuconazole Versus Voriconazole as the First-line Therapy for Solid Organ Transplant Recipients With Invasive Aspergillosis: Comparative Analysis of 2 Multicenter Cohort Studies.

Author

Fernández-Ruiz M, Gioia F, Bodro M, Gutiérrez Martín I, Sabé N, Rodriguez-Álvarez R, Corbella L, López-Viñau T, Valerio M, Illaro A, Salto-Alejandre S, Cordero E, Arnaiz de Las Revillas F, Fariñas MC, Muñoz P, Vidal E, Carratalà J, Goikoetxea J, Ramos-Martínez A, Moreno A, Martín-Dávila P, Fortún J, and Aguado JM

Subjects
Humans, Male, Female, Middle Aged, Retrospective Studies, Treatment Outcome, Aged, Adult, Invasive Fungal Infections drug therapy, Invasive Fungal Infections mortality, Invasive Fungal Infections diagnosis, Transplant Recipients, Antifungal Agents therapeutic use, Antifungal Agents adverse effects, Voriconazole therapeutic use, Voriconazole adverse effects, Nitriles therapeutic use, Nitriles adverse effects, Pyridines therapeutic use, Pyridines adverse effects, Triazoles therapeutic use, Triazoles adverse effects, Organ Transplantation adverse effects, Aspergillosis drug therapy, Aspergillosis mortality, Aspergillosis diagnosis
Abstract

Background: Isavuconazole (ISA) and voriconazole (VORI) are recommended as the first-line treatment for invasive aspergillosis (IA). Despite theoretical advantages of ISA, both triazole agents have not been compared in solid organ transplant recipients., Methods: We performed a post hoc analysis of 2 retrospective multicenter cohorts of solid organ transplant recipients with invasive fungal disease (the SOTIS [Solid Organ Transplantation and ISavuconazole] and DiasperSOT [DIagnosis of ASPERgillosis in Solid Organ Transplantation] studies). We selected adult patients with proven/probable IA that were treated for ≥48 h with ISA (n = 57) or VORI (n = 77) as first-line therapy, either in monotherapy or combination regimen. The primary outcome was the rate of clinical response at 12 wk from the initiation of therapy. Secondary outcomes comprised 12-wk all-cause and IA-attributable mortality and the rates of treatment-emergent adverse events and premature treatment discontinuation., Results: Both groups were comparable in their demographics and major clinical and treatment-related variables. There were no differences in the rate of 12-wk clinical response between the ISA and VORI groups (59.6% versus 59.7%, respectively; odds ratio [OR], 0.99; 95% confidence interval [CI], 0.49-2.00). This result was confirmed after propensity score adjustment (OR, 0.81; 95% CI, 0.32-2.05) and matching (OR, 0.79; 95% CI, 0.31-2.04). All-cause and IA-attributable mortality were also similar. Patients in the ISA group were less likely to experience treatment-emergent adverse events (17.5% versus 37.7%; P = 0.011) and premature treatment discontinuation (8.8% versus 23.4%; P = 0.027)., Conclusions: Front-line treatment with ISA for posttransplant IA led to similar clinical outcomes than VORI, with better tolerability and higher treatment completion., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2024
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49. Prevalence and impact of multidrug-resistant bacteria in solid cancer patients with bloodstream infection: a 25-year trend analysis.

Author

Lopera C, Monzó P, Aiello TF, Chumbita M, Peyrony O, Gallardo-Pizarro A, Pitart C, Cuervo G, Morata L, Bodro M, Herrera S, Del Río A, Martínez JA, Soriano A, Puerta-Alcalde P, and Garcia-Vidal C

Subjects
Humans, Male, Female, Middle Aged, Prevalence, Aged, Adult, Gram-Negative Bacteria drug effects, Gram-Negative Bacteria isolation & purification, Risk Factors, Methicillin-Resistant Staphylococcus aureus drug effects, Vancomycin-Resistant Enterococci drug effects, Aged, 80 and over, Drug Resistance, Multiple, Bacterial, Neoplasms complications, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents pharmacology, Bacteremia microbiology, Bacteremia drug therapy, Bacteremia mortality, Bacteremia epidemiology
Abstract

The study aimed to describe the epidemiology of multidrug-resistant (MDR) bacteria among solid cancer (SC) patients with bloodstream infections (BSIs), evaluating inappropriate empiric antibiotic treatment (IEAT) use and mortality trends over a 25-year period. All BSI occurrences in adult SC patients at a university hospital were analyzed across five distinct five-year intervals. MDR bacteria were classified as extended-spectrum beta-lactamases (ESBL)-producing and/or Carbapenem-resistant Enterobacterales, non-fermenting Gram-negative bacilli (GNB) resistant to at least three antibiotic classes, methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococci . A multivariate regression model identified the risk factors for MDR BSI. Of 6,117 BSI episodes, Gram-negative bacilli (GNB) constituted 60.4% (3,695/6,117), being the most common are Escherichia coli with 26.8% (1,637/6,117), Klebsiella spp. with 12.4% (760/6,117), and Pseudomonas aeruginosa with 8.6% (525/6,117). MDR-GNB accounted for 644 episodes (84.8% of MDR or 644/759), predominantly ESBL-producing strains (71.1% or 540/759), which escalated significantly over time. IEAT was administered in 24.8% of episodes, mainly in MDR BSI, and was associated with higher mortality (22.9% vs. 14%, P < 0.001). Independent factors for MDR BSI were prior antibiotic use [odds ratio (OR) 2.93, confidence interval (CI) 2.34-3.67], BSI during antibiotic treatment (OR 1.46, CI 1.18-1.81), biliary (OR 1.84, CI 1.34-2.52) or urinary source (OR 1.86, CI 1.43-2.43), admission period (OR) 1.28, CI 1.18-1.38, and community-acquired infection (OR 0.57, CI 0.39-0.82). The study showed an increase in MDR-GNB among SC patients with BSI. A quarter received IEAT, which was linked to increased mortality. Improving risk assessment for MDR infections and the judicious prescription of empiric antibiotics are crucial for better outcomes., Importance: Multidrug-resistant (MDR) bacteria pose a global public health threat as they are more challenging to treat, and they are on the rise. Solid cancer patients are often immunocompromised due to their disease and cancer treatments, making them more susceptible to infections. Understanding the changes and trends in bloodstream infections in solid cancer patients is crucial, to help physicians make informed decisions about appropriate antibiotic therapies, manage infections in this vulnerable population, and prevent infection. Solid cancer patients often require intensive and prolonged treatments, including surgery, chemotherapy, and radiation therapy. Infections can complicate these treatments, leading to treatment delays, increased healthcare costs, and poorer patient outcomes. Investigating new strategies to combat MDR infections and researching novel antibiotics in these patients is of paramount importance to avoid these negative impacts., Competing Interests: C.G.-V. has received honoraria for talks on behalf of Gilead Sciences, MSD, Novartis, Pfizer, Janssen, and Lilly, as well as a grant from Gilead Sciences, Pfizer, and MSD. P.P.-A. has received honoraria for talks on behalf of Merck Sharp & Dohme, Gilead, Lilly, ViiV Healthcare, and Gilead Sciences. A.S. has received honoraria for talks on behalf of Merck Sharp & Dohme, Pfizer, Novartis, Angelini, Menarini, and Gilead Sciences, as well as grant support from Pfizer and Gilead Sciences. O.P. has received honoraria for talks on behalf of MSD, Qiagen, and expertise for Sanofi.

Published
2024
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50. Successful BK virus-specific T cell therapy in a kidney transplant recipient with progressive multifocal leukoencephalopathy.

Author

Sempere A, Castillo N, Rudilla F, Querol S, Enrich E, Prat-Vidal C, Codinach M, Cofan F, Torregrossa V, Dieckmann F, and Bodro M

Subjects
Humans, Male, Middle Aged, Prognosis, JC Virus immunology, Transplant Recipients, Cell- and Tissue-Based Therapy methods, Leukoencephalopathy, Progressive Multifocal therapy, Leukoencephalopathy, Progressive Multifocal immunology, Leukoencephalopathy, Progressive Multifocal etiology, Kidney Transplantation adverse effects, BK Virus, T-Lymphocytes immunology, Polyomavirus Infections immunology, Polyomavirus Infections therapy
Abstract

The strategy for progressive multifocal leukoencephalopathy (PML) in solid organ transplant recipients primarily focuses on reducing immunosuppressive therapy. However, this approach offers limited efficacy and carries a high risk of graft loss. Here, we present the case of a 64-year-old male kidney transplant recipient with a high degree of immunosuppression who developed PML in October 2022. Despite the standard reduction of immunosuppressive therapy, the patient's condition continued to deteriorate, as evidenced by worsening neurological symptoms and increasing JC virus (JCV) DNA levels in cerebrospinal fluid. This prompted the innovative use of BKPyV-virus-specific T cell (BKPyV-VST) therapy, given the genetic similarities between BK and JCVs. Infusion of third-party donor BKPyV-VST resulted in clinical stabilization, a significant reduction in JCV-DNA levels, and the emergence of a JCV-specific T cell response, as observed in enzyme-linked immunospot assays and TCRβ sequencing. This represents the first case report of successful third-party BKPyV-VST therapy in a kidney recipient presenting PML, without graft-versus-host disease or graft dysfunction., (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Published
2024
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