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3 results on '"Marinescu, C. I."'

1. A Multinational, Preregistered Cohort Study of β-Lactam/β-Lactamase Inhibitor Combinations for Treatment of Bloodstream Infections Due to Extended-Spectrum-β-Lactamase-Producing Enterobacteriaceae

Author

Belén Gutiérrez Gutiérrez, Salvador Pérez Galera, Elena Salamanca, Marina de Cueto, Esther Calbo, Benito Almirante, VIALE, PIERLUIGI, Antonio Oliver, Vicente Pintado, Oriol Gasch, Luis Martínez Martínez, Johann Pitout, Murat Akova, Carmen Peña, José Molina, Alicia Hernández, Mario Venditti, Nuria Prim, Julia Origüen, German Bou, Evelina Tacconelli, Mario Tumbarello, Axel Hamprecht, Helen Giamarellou, Manel Almela, Federico Pérez, Mitchell J. Schwaber, Joaquín Bermejo, Warren Lowman, Po Ren Hsueh, Marta Mora Rillo, Clara Natera, Maria Souli, Robert A. Bonomo, Yehuda Carmeli, David L. Paterson, Alvaro Pascual, Jesús Rodríguez Baño, the REIPI/ESGBIS/INCREMENT Group [, Gálvez, J., Del Toro, M. D., Retamar, P., Falcone, M., Russo, A., Daikos, G., Karaiskos, I., Trecarichi, E. M., Losito, A. R., Paterson, D. L., García Vázquez, E., Gómez, J., Roilides, E., Iosifidis, E., Doi, Y., Tuon, F. F., Navarro, F., Mirelis, B., San Juan, R., Fernández Ruiz, M., Larrosa, N., Puig, M., Cisneros, J. M., González, V., Rucci, Victoria, Ruiz De Gopegui, E., Marinescu, C. I., Fariñas, M. C., Cano, M. E., Gozalo, M., Paño Pardo, J. R., Navarro San Francisco, C., Gómez Zorrilla, S., Tubau, F., Pournaras, S., Tsakris, A., Zarkotou, O., Azap, Ö. K., Antoniadou, A., Poulakou, G., Virmani, D., Torre Cisneros, J., Pérez Nadales, E., Gracia Ahulfinger, I., Helvaci, Ö., Sahin, A. O., Cantón, R., Ruiz, P., BARTOLETTI, MICHELE, GIANNELLA, MADDALENA, Riemenschneider, F., Badia, C., Xercavins, Mariona, Fontanals, D., Jové, E., Belén Gutiérrez-Gutiérrez, Salvador Pérez-Galera, Elena Salamanca, Marina de Cueto, Esther Calbo, Benito Almirante, Pierluigi Viale, Antonio Oliver, Vicente Pintado, Oriol Gasch, Luis Martínez-Martínez, Johann Pitout, Murat Akova, Carmen Peña, José Molina, Alicia Hernández, Mario Venditti, Nuria Prim, Julia Origüen, German Bou, Evelina Tacconelli, Mario Tumbarello, Axel Hamprecht, Helen Giamarellou, Manel Almela, Federico Pérez, Mitchell J. Schwaber, Joaquín Bermejo, Warren Lowman, Po-Ren Hsueh, Marta Mora-Rillo, Clara Natera, Maria Souli, Robert A. Bonomo, Yehuda Carmeli, David L. Paterson, Alvaro Pascual, Jesús Rodríguez-Baño, the REIPI/ESGBIS/INCREMENT Group [, Gálvez, J., Del Toro, M.D., Retamar, P., Falcone, M., Russo, A., Daikos, G., Karaiskos, I., Trecarichi, E.M., Losito, A.R., Paterson, D.L., García-Vázquez, E., Gómez, J., Roilides, E., Iosifidis, E., Doi, Y., Tuon, F.F., Navarro, F., Mirelis, B., San Juan, R., Fernández-Ruiz, M., Larrosa, N., Puig, M., Cisneros, J.M., González, V., Rucci, Victoria, Ruiz De Gopegui, E., Marinescu, C.I., Fariñas, M.C., Cano, M.E., Gozalo, M., Paño-Pardo, J.R., Navarro-San Francisco, C., Gómez-Zorrilla, S., Tubau, F., Pournaras, S., Tsakris, A., Zarkotou, O., Azap, Ö.K., Antoniadou, A., Poulakou, G., Virmani, D., Torre-Cisneros, J., Pérez-Nadales, E., Gracia-Ahulfinger, I., Helvaci, Ö., Sahin, A.O., Cantón, R., Ruiz, P., Bartoletti, M., Giannella, M., Riemenschneider, F., Badia, C., Xercavins, Mariona, Fontanals, D., Jové, E., ], Ministerio de Economía y Competitividad (España), Instituto de Salud Carlos III, European Commission, Red Española de Investigación en Patología Infecciosa, European Federation of Pharmaceutical Industries and Associations, Cuyahoga County Veterans Service Commission, Geriatric Research Education and Clinical Center (US), National Institute of Allergy and Infectious Diseases (US), National Institutes of Health (US), Peña, Carmen [0000-0002-6673-2883], Peña, Carmen, İç Hastalıkları, Universidad de Sevilla. Departamento de Microbiología, Universidad de Sevilla. Departamento de Medicina, and European Union (UE). FP7

Subjects
0301 basic medicine, Male, Carbapenem, medicine.medical_specialty, Pediatrics, 030106 microbiology, Infectious Disease, Bacteremia, Kaplan-Meier Estimate, Clinical Therapeutics, Settore MED/17 - MALATTIE INFETTIVE, beta-Lactams, Microbiology, beta-Lactamases, 03 medical and health sciences, 0302 clinical medicine, Aged, Anti-Bacterial Agents, Carbapenems, Enterobacteriaceae, Female, Humans, Middle Aged, Multivariate Analysis, Odds Ratio, Retrospective Studies, beta-Lactamase Inhibitors, Internal medicine, medicine, Pharmacology (medical), 030212 general & internal medicine, Pharmacology & Pharmacy, Beta-Lactamase Inhibitors, Pharmacology, business.industry, Mortality rate, Retrospective cohort study, Odds ratio, bacterial infections and mycoses, Confidence interval, 3. Good health, Infectious Diseases, Cohort, business, medicine.drug, Cohort study
Abstract

The spread of extended-spectrum-β-lactamase (ESBL)-producing Enterobacteriaceae (ESBL-E) is leading to increased carbapenem consumption. Alternatives to carbapenems need to be investigated. We investigated whether β-lactam/β-lactamase inhibitor (BLBLI) combinations are as effective as carbapenems in the treatment of bloodstream infections (BSI) due to ESBL-E. A multinational, retrospective cohort study was performed. Patients with monomicrobial BSI due to ESBL-E were studied; specific criteria were applied for inclusion of patients in the empirical-therapy (ET) cohort (ETC; 365 patients), targeted-therapy (TT) cohort (TTC; 601 patients), and global cohort (GC; 627 patients). The main outcome variables were cure/improvement rate at day 14 and all-cause 30-day mortality. Multivariate analysis, propensity scores (PS), and sensitivity analyses were used to control for confounding. The cure/improvement rates with BLBLIs and carbapenems were 80.0% and 78.9% in the ETC and 90.2% and 85.5% in the TTC, respectively. The 30-day mortality rates were 17.6% and 20% in the ETC and 9.8% and 13.9% in the TTC, respectively. The adjusted odds ratio (OR) (95% confidence interval [CI]) values for cure/improvement rate with ET with BLBLIs were 1.37 (0.69 to 2.76); for TT, they were 1.61 (0.58 to 4.86). Regarding 30-day mortality, the adjusted OR (95% CI) values were 0.55 (0.25 to 1.18) for ET and 0.59 (0.19 to 1.71) for TT. The results were consistent in all subgroups studied, in a stratified analysis according to quartiles of PS, in PS-matched cases, and in the GC. BLBLIs, if active in vitro, appear to be as effective as carbapenems for ET and TT of BSI due to ESLB-E regardless of the source and specific species. These data may help to avoid the overuse of carbapenems. (This study has been registered at ClinicalTrials.gov under registration no. NCT01764490.), The work was funded by the Ministerio de Economía y Competitividad, Instituto de Salud Carlos III, cofinanced by European Development Regional Fund titled A Way To Achieve Europe ERDF, the Spanish Network for Research in Infectious Diseases (REIPI RD12/0015), and FIS (PI10/02021). Participants in the study received support for research from the Innovative Medicines Initiative Joint Undertaking under the Combatting Bacterial Resistance in Europe—Molecule against Gram Negative Infections (COMBACTE-MAGNET) agreement 115737 resources, which are composed of financial contributions from the European Union's Seventh Framework Programme (FP7/2007-2013) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) companies' in kind contributions (A. Pascua and J. Rodríguez-Baño), the Cleveland Department of Veterans Affairs, the Veterans Affairs Merit Review Program, the Geriatric Research Education and Clinical Center VISN 10 (VISN 10 GRECC), and NIAID, NIH, under award numbers R01AI072219 and R01AI063517 (R. A. Bonomo).

Published
2016

2. A Predictive Model of Mortality in Patients With Bloodstream Infections due to Carbapenemase-Producing Enterobacteriaceae

Author

Gutiérrez Gutiérrez, Belén, Salamanca, Elena, de Cueto, Marina, Pascual, Alvaro, Rodríguez Baño, Jesús, Hsueh, Po Ren, Viale, Pierluigi, Paño Pardo, José Ramón, Venditti, Mario, Tumbarello, Mario, Daikos, George, Pintado, Vicente, Doi, Yohei, Tuon, Felipe Francisco, Karaiskos, Ilias, Machuca, Isabel, Schwaber, Mitchell J., Azap, Özlem Kurt, Souli, Maria, Roilides, Emmanuel, Pournaras, Spyros, Akova, Murat, Pérez, Federico, Bonomo, Robert A., Bermejo, Joaquín, Oliver, Antonio, Almela, Manel, Lowman, Warren, Almirante, Benito, Carmeli, Yehuda, Paterson, David L., Falcone, M., Russo, A., Giamarellou, H., Trecarichi, Enrico Maria, Losito, Angela Raffaella, García Vázquez, E., Hernández, A., Gómez, J., Iosifidis, E., Prim, N., Navarro, F., Mirelis, B., Origüen, J., San Juan, R., Fernández Ruiz, M., Larrosa, N., Puig Asensio, M., Cisneros, J. M., Molina, J., González, V., Rucci, V., Ruiz de Gopegui, E., Marinescu, C. I., Martínez Martínez, L., Fariñas, M. C., Cano, M. E., Gozalo, M., Mora Rillo, M., Navarro San Francisco, C., Peña, C., Gómez Zorrilla, S., Tubau, F., Tsakris, A., Zarkotou, O., Azap, Ö. K., Pitout, J., Virmani, D., Torre Cisneros, J., Natera, C., Helvaci, Ö., Sahin, A. O., Cantón, R., Ruiz, P., Bartoletti, M., Giannella, M., Taconelli, E., Riemenschneider, F., Calbo, E., Badia, C., Xercavins, M., Gasch, E., Fontanals, D., and Jové, E.

Subjects
0301 basic medicine, Male, medicine.medical_specialty, carbapenems, klebsiella pneumoniae, pneumoniae carbapenemase, 030106 microbiology, Bacteremia, Comorbidity, Logistic regression, Settore MED/17 - MALATTIE INFETTIVE, Sensitivity and Specificity, beta-Lactamases, Decision Support Techniques, 03 medical and health sciences, 0302 clinical medicine, Bacterial Proteins, Enterobacteriaceae, Predictive Value of Tests, Internal medicine, medicine, Humans, In patient, 030212 general & internal medicine, Aged, Anti-Bacterial Agents, Enterobacteriaceae Infections, Female, Logistic Models, Middle Aged, Retrospective Studies, Receiver operating characteristic, business.industry, Medicine (all), Retrospective cohort study, General Medicine, medicine.disease, Surgery, Predictive value of tests, Observational study, business
Abstract

Objective To develop a score to predict mortality in patients with bloodstream infections (BSIs) due to carbapenemase-producing Enterobacteriaceae (CPE). Patients and Methods A multinational retrospective cohort study (INCREMENT project) was performed from January 1, 2004, through December 31, 2013. Patients with clinically relevant monomicrobial BSIs due to CPE were included and randomly assigned to either a derivation cohort (DC) or a validation cohort (VC). The variables were assessed on the day the susceptibility results were available, and the predictive score was developed using hierarchical logistic regression. The main outcome variable was 14-day all-cause mortality. The predictive ability of the model and scores were measured by calculating the area under the receiver operating characteristic curve. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were calculated for different cutoffs of the score. Results The DC and VC included 314 and 154 patients, respectively. The final logistic regression model of the DC included the following variables: severe sepsis or shock at presentation (5 points); Pitt score of 6 or more (4 points); Charlson comorbidity index of 2 or more (3 points); source of BSI other than urinary or biliary tract (3 points); inappropriate empirical therapy and inappropriate early targeted therapy (2 points). The score exhibited an area under the receiver operating characteristic curve of 0.80 (95% CI, 0.74-0.85) in the DC and 0.80 (95% CI, 0.73-0.88) in the VC. The results for 30-day all-cause mortality were similar. Conclusion A validated score predictive of early mortality in patients with BSIs due to CPE was developed. Trial Registration clinicaltrials.gov Identifier: NCT01 764490.

Published
2016

3. Ertapenem for the treatment of bloodstream infections due to ESBL-producing Enterobacteriaceae: A multinational pre-registered cohort study

Author

Gutiérrez-Gutiérrez, Belén, Bonomo Robert, A., Carmeli, Yehuda, Paterson David, L., Almirante, Benito, Martínez-Martínez, Luis, Oliver, Antonio, Calbo, Esther, Peña, Carmen, Akova, Murat, Pitout, Johann, Origüen, Julia, Pintado, Vicente, García-Vázquez, Elisa, Gasch, Oriol, Hamprecht, Axel, Prim, Nuria, Tumbarello, Mario, Bou, German, Viale, Pierluigi, Tacconelli, Evelina, Almela, Manel, Pérez, Federico, Giamarellou, Helen, Cisneros José Miguel, Schwaber Mitchell, J., Venditti, Mario, Lowman, Warren, Bermejo, Joaquín, Hsueh, Po-Ren, Mora-Rillo, Marta, Gracia-Ahulfinger, Irene, Pascual, Alvaro, Rodríguez-Baño, Jesús, Karaiskos, I., Trecarichi, E. M., Losito, A. R., Hernández, A., Gómez, J., Navarro, F., Mirelis, B., Larrosa, N., Puig, M., Rucci, V., Bartoletti, M., Giannella, M., Riemenschneider, F., Badia, C., Xercavins, M., Gálvez, J., de Cueto, M., Salamanca, E., Falcone, M., Russo, A., Daikos, G., Paterson, D. L., Roilides, E., Iosifidis, E., Doi, Y., Tuon, F. F., San Juan, R., Fernández-Ruiz, M., Molina, J., González, V., Ruiz de Gopegui, E., Marinescu, C. I., Fariñas, M. C., Cano, M. E., Gozalo, M., Paño-Pardo, J. R., Navarro-San Francisco, C., Gómez-Zorrilla, S., Tubau, F., Pournaras, S., Tsakris, A., Zarkotou, O., Azap, Ö. K., Souli, M., Antoniadou, A., Poulakou, G., Virmani, D., Machuca, I., Pérez-Nadales, E., Torre-Cisneros, J., Helvaci, Ö., Sahin, A. O., Cantón, R., Ruiz, P., Fontanals, D., Jové, E., Ministerio de Economía y Competitividad (España), Instituto de Salud Carlos III, European Commission, Red Española de Investigación en Patología Infecciosa, US Department of Veterans Affairs, Geriatric Research Education and Clinical Center (US), National Institute of Allergy and Infectious Diseases (US), National Institutes of Health (US), and İç Hastalıkları

Subjects
0301 basic medicine, Male, Carbapenem, Pediatrics, chemistry.chemical_compound, Septic shock, polycyclic compounds, Molecular targeted therapy, Pharmacology (medical), Pharmacology & Pharmacy, Original Research, Enterobacteriaceae Infections, Middle Aged, Anti-Bacterial Agents, Treatment Outcome, Infectious Diseases, Cohort, Female, Sensitivity analysis, Ertapenem, medicine.drug, Cohort study, Microbiology (medical), medicine.medical_specialty, Aged, Carbapenems, Enterobacteriaceae, Humans, Retrospective Studies, Sepsis, Survival Analysis, beta-Lactamases, beta-Lactams, 030106 microbiology, Settore MED/17 - MALATTIE INFETTIVE, Microbiology, 03 medical and health sciences, Severe extended-spectrum beta lactamases, Internal medicine, medicine, Mortality, Pharmacology, business.industry, Retrospective cohort study, biochemical phenomena, metabolism, and nutrition, medicine.disease, bacterial infections and mycoses, chemistry, Propensity score matching, bacteria, Bloodstream infections, business, human activities
Abstract

REIPI/ESGBIS/INCREMENT Group: J. Gálvez, M. de Cueto, E. Salamanca, M. Falcone, A. Russo, G. Daikos, I. Karaiskos, E. M. Trecarichi, A. R. Losito, D. L. Paterson, A. Hernández, J. Gómez, E. Roilides, E. Iosifidis, Y. Doi, F. F. Tuon, F. Navarro, B. Mirelis, R. San Juan, M. Fernández-Ruiz, N. Larrosa, M. Puig, J. Molina, V. González, V. Rucci, E. Ruiz de Gopegui, C. I. Marinescu, M. C. Fariñas, M. E. Cano, M. Gozalo, J. R. Paño-Pardo, C. Navarro-San Francisco, S. Gómez-Zorrilla, F. Tubau, S. Pournaras, A. Tsakris, O. Zarkotou, Ö. K. Azap, M. Souli, A. Antoniadou, G. Poulakou, D. Virmani, I. Machuca, E. Pérez-Nadales, J. Torre-Cisneros, Ö. Helvaci, A. O. Sahin, R. Cantón, P. Ruiz, M. Bartoletti, M. Giannella, F. Riemenschneider, C. Badia, M. Xercavins, D. Fontanals, E. Jové., [Objectives] Data about the efficacy of ertapenem for the treatment of bloodstream infections (BSI) due to ESBL-producing Enterobacteriaceae (ESBL-E) are limited. We compared the clinical efficacy of ertapenem and other carbapenems in monomicrobial BSI due to ESBL-E., [Methods] A multinational retrospective cohort study (INCREMENT project) was performed (ClinicalTrials.gov identifier: NCT01764490). Patients given monotherapy with ertapenem or other carbapenems were compared. Empirical and targeted therapies were analysed. Propensity scores were used to control for confounding; sensitivity analyses were performed in subgroups. The outcome variables were cure/improvement rate at day 14 and all-cause 30 day mortality., [Results] The empirical therapy cohort (ETC) and the targeted therapy cohort (TTC) included 195 and 509 patients, respectively. Cure/improvement rates were 90.6% with ertapenem and 75.5% with other carbapenems (P = 0.06) in the ETC and 89.8% and 82.6% (P = 0.02) in the TTC, respectively; 30 day mortality rates were 3.1% and 23.3% (P = 0.01) in the ETC and 9.3% and 17.1% (P = 0.01) in the TTC, respectively. Adjusted ORs (95% CI) for cure/improvement with empirical and targeted ertapenem were 1.87 (0.24–20.08; P = 0.58) and 1.04 (0.44–2.50; P = 0.92), respectively. For the propensity-matched cohorts it was 1.18 (0.43–3.29; P = 0.74). Regarding 30 day mortality, the adjusted HR (95% CI) for targeted ertapenem was 0.93 (0.43–2.03; P = 0.86) and for the propensity-matched cohorts it was 1.05 (0.46–2.44; P = 0.90). Sensitivity analyses were consistent except for patients with severe sepsis/septic shock, which showed a non-significant trend favouring other carbapenems., [Conclusions] Ertapenem appears as effective as other carbapenems for empirical and targeted therapy of BSI due to ESBL-E, but further studies are needed for patients with severe sepsis/septic shock., This study was funded by the Ministerio de Economía y Competitividad, Instituto de Salud Carlos III - co-financed by European Development Regional Fund ‘A way to achieve Europe’ ERDF, Spanish Network for the Research in Infectious Diseases (REIPI RD12/0015) and FIS (PI10/02021). The study was also supported in part by funds and/or facilities provided by the Cleveland Department of Veterans Affairs, the Veterans Affairs Merit Review Program and the Geriatric Research Education and Clinical Center VISN 10 (VISN 10 GRECC) to R. A. B. The NIAID of the NIH under Award Numbers R01AI072219 and R01AI063517 also supported R. A. B.

Published
2016

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