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1. Frequency of bloodstream infections caused by six key antibiotic-resistant pathogens for prioritization of research and discovery of new therapies in Europe: a systematic review.

Author

Pezzani MD, Arieti F, Rajendran NB, Barana B, Cappelli E, De Rui ME, Galia L, Hassoun-Kheir N, Argante L, Schmidt J, Rodriguez-Bano J, Harbarth S, de Kraker M, Gladstone BP, and Tacconelli E

Subjects
Europe epidemiology, Humans, Drug Resistance, Bacterial, Incidence, Prevalence, Carbapenems pharmacology, Bacteremia epidemiology, Bacteremia microbiology, Bacteremia drug therapy, Anti-Bacterial Agents pharmacology, Anti-Bacterial Agents therapeutic use
Abstract

Background: To prioritize healthcare investments, ranking of infections caused by antibiotic-resistant bacteria should be based on accurate incidence data., Objectives: We performed a systematic review to estimate frequency measures of antimicrobial resistance for six key bacteria causing bloodstream infections (BSI) in European countries., Data Sources: We searched PubMed, Web of Science, Embase databases, and the ECRAID-Base Epidemiological-Network platform., Study Eligibility Criteria: We included studies and surveillance systems assessing resistance-percentage, prevalence, or incidence-density of BSI because of carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Escherichia coli, third-generation cephalosporins-resistant E. coli and K. pneumoniae, vancomycin-resistant Enterococcus faecium, and methicillin-resistant Staphylococcus aureus., Methods: Reviewers independently assessed published data and evaluated study quality with the modified Joanna Briggs Institute critical appraisal tool. Pooled estimates were determined using random effects meta-analysis. Consistency of data was assessed using random effects meta-regression (Wald test, p > 0.05)., Results: We identified 271 studies and 52 surveillance systems from 32 European countries. Forty-five studies (16%) reported on BSI, including 180 frequency measures most commonly as resistance-percentage (88, 48.9%). Among 309 frequency measures extracted from 24 (46%) surveillance systems, 278 (89%) were resistance-percentages. Frequency measures of methicillin-resistant S. aureus and vancomycin-resistant E. faecium BSI were more frequently reported from Southern Europe and Western Europe (80%), whereas carbapenem-resistant P. aeruginosa BSI from Northern Europe and Western Europe (88%). Highest resistance-percentages were detected for carbapenem-resistant A. baumannii (66% in Central Eastern Europe) and carbapenem-resistant K. pneumoniae (62.8% in Southern Europe). Pooled estimates showed lower resistance-percentages in community versus healthcare-associated infections and in children versus adults. Estimates from studies and surveillance systems were mostly consistent among European regions. The included data was of medium quality., Discussion: Pathogen-specific frequency measures of antimicrobial resistance in BSI are insufficient to inform antibiotic stewardship and research and development strategies. Improving data collection and standardization of frequency measures is urgently needed., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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2. Combination versus monotherapy as definitive treatment for Pseudomonas aeruginosa bacteraemia: a multicentre retrospective observational cohort study.

Author

Babich T, Naucler P, Valik JK, Giske CG, Benito N, Cardona R, Rivera A, Pulcini C, Abdel Fattah M, Haquin J, MacGowan A, Grier S, Gibbs J, Chazan B, Yanovskay A, Ami RB, Landes M, Nesher L, Zaidman-Shimshovitz A, McCarthy K, Paterson DL, Tacconelli E, Buhl M, Mauer S, Rodriguez-Bano J, Morales I, Oliver A, Ruiz de Gopegui E, Cano A, Machuca I, Gozalo-Marguello M, Martinez LM, Gonzalez-Barbera EM, Alfaro IG, Salavert M, Beovic B, Saje A, Mueller-Premru M, Pagani L, Vitrat V, Kofteridis D, Zacharioudaki M, Maraki S, Weissman Y, Paul M, Dickstein Y, Leibovici L, and Yahav D

Subjects
Anti-Bacterial Agents therapeutic use, Cohort Studies, Drug Therapy, Combination, Humans, Pseudomonas aeruginosa, Retrospective Studies, Treatment Outcome, Bacteremia drug therapy, Pseudomonas Infections drug therapy
Abstract

Background: Pseudomonas aeruginosa bacteraemia is a common and serious infection. No consensus exists regarding whether definitive combination therapy is superior to monotherapy. We aimed to evaluate the impact of combination therapy on mortality., Methods: This was a multicentre retrospective study (nine countries, 25 centres), including 1277 patients with P. aeruginosa bacteraemia during 2009-15. We evaluated the association between β-lactam plus aminoglycoside or quinolone combination therapy versus β-lactam monotherapy and mortality. The primary outcome was 30 day all-cause mortality. Univariate and multivariate Cox regression analyses were conducted, introducing combination as a time-dependent variable. Propensity score was conducted to adjust for confounding for choosing combination therapy over monotherapy., Results: Of 1119 patients included, 843 received definitive monotherapy and 276 received combination therapy (59% aminoglycoside and 41% quinolone). Mortality at 30 days was 16.9% (189/1119) and was similar between combination (45/276; 16.3%) and monotherapy (144/843; 17.1%) groups (P = 0.765). In multivariate Cox regression, combination therapy was not associated with reduced mortality (HR 0.98, 95% CI 0.64-1.53). No advantage in terms of clinical failure, microbiological failure or recurrent/persistent bacteraemia was demonstrated using combination therapy. Likewise, adverse events and resistance development were similar for the two regimens., Conclusions: In this retrospective cohort, no mortality advantage was demonstrated using combination therapy over monotherapy for P. aeruginosa bacteraemia. Combination therapy did not improve clinical or microbiological failure rates, nor affect adverse events or resistance development. Our finding of no benefit with combination therapy needs confirmation in well-designed randomized controlled trials., (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2021
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3. Risk factors for mortality among patients with Pseudomonas aeruginosa bacteraemia: a retrospective multicentre study.

Author

Babich T, Naucler P, Valik JK, Giske CG, Benito N, Cardona R, Rivera A, Pulcini C, Fattah MA, Haquin J, MacGowan A, Grier S, Chazan B, Yanovskay A, Ami RB, Landes M, Nesher L, Zaidman-Shimshovitz A, McCarthy K, Paterson DL, Tacconelli E, Buhl M, Maurer S, Rodriguez-Bano J, Morales I, Oliver A, de Gopegui ER, Cano A, Machuca I, Gozalo-Marguello M, Martinez-Martinez L, Gonzalez-Barbera EM, Alfaro IG, Salavert M, Beovic B, Saje A, Mueller-Premru M, Pagani L, Vitrat V, Kofteridis D, Zacharioudaki M, Maraki S, Weissman Y, Paul M, Dickstein Y, Leibovici L, and Yahav D

Subjects
Aged, Anti-Bacterial Agents therapeutic use, Bacteremia microbiology, Female, Humans, Male, Middle Aged, Pseudomonas Infections microbiology, Retrospective Studies, Risk Factors, Bacteremia mortality, Pseudomonas Infections mortality, Pseudomonas aeruginosa isolation & purification
Abstract

This study aimed to evaluate risk factors for 30-day mortality among hospitalised patients with Pseudomonas aeruginosa bacteraemia, a highly fatal condition. A retrospective study was conducted between 1 January 2009 and 31 October 2015 in 25 centres (9 countries) including 2396 patients. Univariable and multivariable analyses of risk factors were conducted for the entire cohort and for patients surviving ≥48 h. A propensity score for predictors of appropriate empirical therapy was introduced into the analysis. Of the 2396 patients, 636 (26.5%) died within 30 days. Significant predictors (odds ratio and 95% confidence interval) of mortality in the multivariable analysis included patient-related factors: age (1.02, 1.01-1.03); female sex (1.34, 1.03-1.77); bedridden functional capacity (1.99, 1.24-3.21); recent hospitalisation (1.43, 1.07-1.92); concomitant corticosteroids (1.33, 1.02-1.73); and Charlson comorbidity index (1.05, 1.01-1.93). Infection-related factors were multidrug-resistant Pseudomonas (1.52, 1.15-2.1), non-urinary source (2.44, 1.54-3.85) and Sequential Organ Failure Assessment (SOFA) score (1.27, 1.18-1.36). Inappropriate empirical therapy was not associated with increased mortality (0.81, 0.49-1.33). Among 2135 patients surviving ≥48 h, hospital-acquired infection (1.59, 1.21-2.09), baseline endotracheal tube (1.63, 1.13-2.36) and ICU admission (1.53, 1.02-2.28) were additional risk factors. Risk factors for mortality among patients with P. aeruginosa were mostly irreversible. Early appropriate empirical therapy was not associated with reduced mortality. Further research should be conducted to explore subgroups that may not benefit from broad-spectrum antipseudomonal empirical therapy. Efforts should focus on prevention of infection, mainly hospital-acquired infection and multidrug-resistant pseudomonal infection., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2020
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5. Impact of an Evidence-Based Bundle Intervention in the Quality-of-Care Management and Outcome of Staphylococcus aureus Bacteremia

Author

REIPI/SAB group, López-Cortés, Luis E., del Toro, Maria Dolores, Gálvez-Acebal, Juan, Bereciartua-Basterrica, Elena, Fariñas, María Carmen, Sanz-Franco, Mercedes, Natera, Clara, Corzo, Juan E., Lomas, José Manuel, Pasquau, Juan, del Arco, Alfonso, Martínez, María Paz, Romero, Alberto, Muniain, Miguel A., de Cueto, Marina, Pascual, Álvaro, and Rodríguez-Baño, Jesús

Published
2013
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6. Effect of Adequate Single-Drug vs Combination Antimicrobial Therapy on Mortality in Pseudomonas aeruginosa Bloodstream Infections: A Post Hoc Analysis of a Prospective Cohort

Author

Spanish Network for Research in Infectious Diseases (REIPI), Peña, Carmen, Suarez, Cristina, Ocampo-Sosa, Alain, Murillas, Javier, Almirante, Benito, Pomar, Virginia, Aguilar, Manuela, Granados, Ana, Calbo, Esther, Rodríguez-Baño, Jesús, Rodríguez, Fernando, Tubau, Fe, Oliver, Antonio, and Martínez-Martínez, Luis

Published
2013
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9. Reply to Tarchini

Author

Rodríguez-Baño, Jesús and Pascual, Álvaro

Published
2010

11. Impact of antibiotic resistance on outcomes of neutropenic cancer patients with Pseudomonas aeruginosa bacteraemia (IRONIC study): study protocol of a retrospective multicentre international study

Author

Albasanz-Puig, Adaia, Gudiol, Carlota, Parody, Rocio, Tebe, Cristian, Akova, Murat, Araos, Rafael, Bote, Anna, Brunel, Anne-Sophie, Calik, Sebnem, Drgona, Lubos, Garcia, Estefania, Hemmati, Philipp, Herrera, Fabian, Ibrahim, Karim Yaqub, Isler, Burcu, Kanj, Souha, Kern, Winfried, Maestro de la Calle, Guillermo, Manzur, Adriana, Ivan Marin, Jorge, Marquez-Gomez, Ignacio, Martin-Davila, Pilar, Mikulska, Malgorzata, Montejo, Jose Miguel, Montero, Milagros, Paz Morales, Hugo Manuel, Morales, Isabel, Novo, Andres, Oltolini, Chiara, Peghin, Maddalena, Luis del Pozo, Jose, Puerta-Alcalde, Pedro, Ruiz-Camps, Isabel, Resat Sipahi, Oguz, Tilley, Robert, Yanez, Lucrecia, Ribeiro Gomes, Marisa Zenaide, Carratala, Jordi, Cuervo, Guillermo, Escrihuela-Vidal, Francesc, Tubau, Fe, Rodriguez Arias, Marisol, Merve Ayaz, Caglayan, Munita, Jose, Gasch, Oriol, Capilla, Silvia, Bochud, Pierre-Yves, Manuel, Oriol, Torre-Cisneros, Julian, Tabares, Salvador, Serrano Lopez, Josefina, Maschmeyer, Georg, Torres, Diego, Abdala, Edson, Bittencourt, Driele Peixoto, El Zein, Saeed, Jabbour, Jean-Francois, Bertz, Hartmut, Peyerl-Hoffmann, Gabriele, Lizasoain, Manuel, Maria Aguado, Jose, Clemencia Correa, Lina, Palop, Begona, Fortun, Jesus, Magnasco, Laura, Cespedes, Roberto, Lopez-Soria, Leire, Pablo Horcajada, Juan, Montaguti, Mia Hold, de Cueto, Marina, Rodriguez-Bano, Jesus, Greco, Raffaella, Cichero, Paola, Bassetti, Matteo, Castaldo, Nadia, Sangro del Alcazar, Paloma, Cardozo, Celia, Garcia-Vidal, Carolina, Aguilar-Company, Juan, Larrosa, Nieves, Uyan-Onal, Ayse, Nazli-Zeka, Arzu, Vasconcelos de Freitas, Wania, da Silva Machado, Amanda Aparecida, IRONIC Study Grp, Instituto de Salud Carlos III, Ministerio de Economía, Industria y Competitividad (España), European Commission, IRONIC study group, Cuervo, G., Escrihuela-Vidal, F., Arias, M.R., Ayaz, C.M., Munita, J., Gasch, O., Bochud, P.Y., Manuel, O., Torres, D., Zein, S.E., Jabbour, J.F., Bertz, H., Peyerl-Hoffmann, G., Lizasoain, M., Aguado, J.M., Palop, B., Fortún, J., Maschmeyer, G., Magnasco, L., Céspedes, R., López-Soria, L., Horcajada, J.P., Montaguti, M.H., Cueto, M., Rodríguez-Baño, J., Greco, R., Cichero, P., Bassetti, M., Castaldo, N., Del Alcázar, P.S., Cardozo, C., Garcia-Vidal, C., Aguilar-Company, J., Larrosa, N., Uyan-Onal, A., Nazli-Zeka, A., Eylul, D., Turkey, I., Clemencia Correa, L., de Freitas, W.V., da Silva Machado, A.A., Institut Català de la Salut, [Albasanz-Puig A, Gudiol C] Departament de Malalties Infeccioses, Hospital Universitari de Bellvitge, Barcelona, Spain. Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain. Universitat de Barcelona, Barcelona, Spain. Spanish Network for Research in Infectious Diseases (REIPI), Instituto de Salud Carlos III, Madrid, Spain. [Parody R] Departament d’hematologia, Institut Català d' Oncologia (ICO) Barcelona, Spain. Hospital Duran i Reynals, Barcelona, Spain. . Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain. [Tebe C] Servei d’estadística, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain. Universitat Rovira i Virgili, Barcelona, Spain. [Akova M] Infectious Diseases Department, Hacettepe University School of Medicine, Ankara, Turkey. [Araos R] Infectious Diseases Department, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Santiago de Chile, Chile. [Ruiz-Camps I] Servei de Malalties Infeccioses, Hospital Universitari Vall d'Hebron, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, and Ege Üniversitesi

Subjects
Microbiological Phenomena::Drug Resistance, Microbial [PHENOMENA AND PROCESSES], Research design, infecciones bacterianas y micosis::infecciones bacterianas y micosis::infección::sepsis::bacteriemia [ENFERMEDADES], bacteraemia, Time Factors, modelos logísticos, International Cooperation, humanos, resistencia a medicamentos, Drug Resistance, Bacteremia, Bacteria::bacterias gramnegativas::bacterias aerobias gramnegativas::bacilos y cocos aerobios gramnegativos::Pseudomonadaceae::Pseudomonas::Pseudomonas aeruginosa [ORGANISMOS], bloodstream infection, multidrug-resistant, neutropenia, onco-haematological patients, pseudomonas aeruginosa, estudios multicéntricos como asunto, Bacterièmia, 0302 clinical medicine, Bacteria::Gram-Negative Bacteria::Gram-Negative Aerobic Bacteria::Gram-Negative Aerobic Rods and Cocci::Pseudomonadaceae::Pseudomonas::Pseudomonas aeruginosa [ORGANISMS], Drug Resistance, Multiple, Bacterial, Neoplasms, Clinical endpoint, Onco-haematological patients, Multicenter Studies as Topic, Multidrug-resistant, Microorganismes - Resistència als medicaments, Otros calificadores::Otros calificadores::/inmunología [Otros calificadores], 030212 general & internal medicine, neoplasias, 0303 health sciences, Neutropènia, fenómenos microbiológicos::farmacorresistencia microbiana [FENÓMENOS Y PROCESOS], Incidence (epidemiology), bacteriemia, General Medicine, Bacterial Infections and Mycoses::Bacterial Infections and Mycoses::Infection::Sepsis::Bacteremia [DISEASES], Anti-Bacterial Agents, Malalts de càncer, Observational Studies as Topic, Research Design, Pseudomonas aeruginosa, Ceftolozane, antibacterianos, medicine.drug, medicine.medical_specialty, Tazobactam, Neutropenia, Pseudomones aeruginosa, Bloodstream infection, 03 medical and health sciences, factores de tiempo, Other subheadings::Other subheadings::/immunology [Other subheadings], Internal medicine, Pseudomonas, medicine, Humans, Pseudomonas Infections, Anti-Bacterial Agents/therapeutic use, Bacteremia/drug therapy, Bacteremia/mortality, Cephalosporins/therapeutic use, Logistic Models, Neoplasms/complications, Neutropenia/complications, Pseudomonas Infections/drug therapy, Pseudomonas aeruginosa/isolation & purification, Retrospective Studies, Tazobactam/therapeutic use, Resistència als medicaments, infecciones por Pseudomonas, cefalosporinas, 030306 microbiology, business.industry, estudios retrospectivos, enfermedades hematológicas y linfáticas::enfermedades hematológicas::trastornos leucocitarios::leucopenia::agranulocitosis::neutropenia [ENFERMEDADES], cooperación internacional, Retrospective cohort study, Cancer patients, medicine.disease, Cephalosporins, Drug resistance, Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia [DISEASES], Bacteraemia, Observational study, business, diseño de la investigación
Abstract

The IRONIC study group: Cuervo, Guillermo; Escrihuela-Vidal, Francesc; Tubau, Fe; Rodriguez Arias, Marisol; Merve Ayaz, Caglayan; Munita, Jose; Gasch, Oriol; Capilla, Silvia; Bochud, Pierre-Yves; Manuel, Oriol; Torre-Cisneros, Julian; Tabares, Salvador; Serrano Lopez, Josefina; Maschmeyer, Georg; Torres, Diego; Abdala, Edson; Bittencourt, Driele Peixoto; El Zein, Saeed; Jabbour, Jean-Francois; Bertz, Hartmut; Peyerl-Hoffmann, Gabriele; Lizasoain, Manuel; Maria Aguado, Jose; Clemencia Correa, Lina; Palop, Begona; Fortun, Jesus; Magnasco, Laura; Cespedes, Roberto; Lopez-Soria, Leire; Pablo Horcajada, Juan; Montaguti, Mia Hold; de Cueto, Marina; Rodriguez-Bano, Jesus; Greco, Raffaella; Cichero, Paola; Bassetti, Matteo; Castaldo, Nadia; Sangro del Alcazar, Paloma; Cardozo, Celia; Garcia-Vidal, Carolina; Aguilar-Company, Juan; Larrosa, Nieves; Uyan-Onal, Ayse; Nazli-Zeka, Arzu; Vasconcelos de Freitas, Wania; da Silva Machado, Amanda Aparecida, [Introduction]: Pseudomonas aeruginosa (PA) has historically been one of the major causes of severe sepsis and death among neutropenic cancer patients. There has been a recent increase of multidrug-resistant PA (MDRPA) isolates that may determine a worse prognosis, particularly in immunosuppressed patients. The aim of this study is to establish the impact of antibiotic resistance on the outcome of neutropenic onco-haematological patients with PA bacteraemia, and to identify the risk factors for MDRPA bacteraemia and mortality., [Methods and analysis]: This is a retrospective, observational, multicentre, international study. All episodes of PA bacteraemia occurring in neutropenic oncohaematological patients followed up at the participating centres from 1 January 2006 to 31 May 2018 will be retrospectively reviewed. The primary end point will be overall case-fatality rate within 30 days of onset of PA bacteraemia. The secondary end points will be to describe the following: the incidence and risk factors for multidrugresistant and extremely drug-resistant PA bacteraemia (by comparing the episodes due to susceptible PA with those produced by MDRPA), the efficacy of ceftolozane/tazobactam, the rates of persistent bacteraemia and bacteraemia relapse and the risk factors for very early (48 hours), early (7 days) and overall (30 days) case-fatality rates., [Ethics and dissemination]: The Clinical Research Ethics Committee of Bellvitge University Hospital approved the protocol of the study at the primary site. To protect personal privacy, identifying information of each patient in the electronic database will be encrypted. The processing of the patients’ personal data collected in the study will comply with the Spanish Data Protection Act of 1998 and with the European Directive on the privacy of data. All data collected, stored and processed will be anonymised. Results will be reported at conferences and in peerreviewed publications., This study 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 Economía, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001) and co-financed by European Development Regional Fund “A way to achieve Europe”, Operative Programme Intelligent Growth 2014‐2020.

Published
2019
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12. Mortality Associated with Bacteremia Due to Colistin-Resistant Klebsiella pneumoniae with High-Level Meropenem Resistance: Importance of Combination Therapy without Colistin and Carbapenems

Author

Irene Gracia-Ahufinger, Elena Pérez-Nadales, Julia Guzmán-Puche, Jesús Rodríguez-Baño, Belén Gutiérrez-Gutiérrez, Clara Natera, Marina Rodríguez, Fernando Rodríguez-López, Rafael León, Isabel Machuca, Juan José Castón, Julián Torre-Cisneros, Francisco Rivera Espinar, Angela Cano, Instituto de Salud Carlos III, Ministerio de Economía y Competitividad (España), Red Española de Investigación en Patología Infecciosa, European Commission, [Machuca, Isabel] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Infect Dis Unit, Cordoba, Spain, [Cano, Angela] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Infect Dis Unit, Cordoba, Spain, [Perez-Nadales, Elena] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Infect Dis Unit, Cordoba, Spain, [Natera, Clara] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Infect Dis Unit, Cordoba, Spain, [Caston, Juan J.] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Infect Dis Unit, Cordoba, Spain, [Torre-Cisneros, Julian] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Infect Dis Unit, Cordoba, Spain, [Gutierrez-Gutierrez, Belen] Univ Seville, Hosp Univ Virgen Macarena IBiS, Infect Dis & Clin Microbiol Unit, Seville, Spain, [Rodriguez-Bano, Jesus] Univ Seville, Hosp Univ Virgen Macarena IBiS, Infect Dis & Clin Microbiol Unit, Seville, Spain, [Gutierrez-Gutierrez, Belen] Univ Seville, Dept Med, Seville, Spain, [Rodriguez-Bano, Jesus] Univ Seville, Dept Med, Seville, Spain, [Gracia-Ahufinger, Irene] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Microbiol Unit, Cordoba, Spain, [Guzman-Puche, Julia] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Microbiol Unit, Cordoba, Spain, [Rodriguez-Lopez, Fernando] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Microbiol Unit, Cordoba, Spain, [Rivera Espinar, Francisco] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Intens Care Unit, Cordoba, Spain, [Rodriguez, Marina] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Intens Care Unit, Cordoba, Spain, [Leon, Rafael] Univ Cordoba, Hosp Univ Reina Sofia IMIBIC, Intens Care Unit, Cordoba, Spain, European Development Regional Fund, and Planes Nacionales de, Instituto de Salud Carlos III, Subdireccion General de Redes y Centros de Investigacion Cooperativa, Ministerio de Economia y Competitividad, Spanish Network for Research in Infectious Diseases

Subjects
Male, 0301 basic medicine, Imipenem, Carbapenem, Minocycline, Bacteremia, Definitions, Tigecycline, Drug Resistance, Multiple, Bacterial, polycyclic compounds, Pharmacology (medical), Prospective Studies, Blood-stream infections, Gentamicin, Hazard ratio, Middle Aged, Shock, Septic, Anti-Bacterial Agents, Drug Combinations, Klebsiella pneumoniae, Impact, Infectious Diseases, K.-pneumoniae, carbapenems, Female, medicine.drug, medicine.medical_specialty, Combination therapy, 030106 microbiology, Outcomes, Emergence, Microbial Sensitivity Tests, Clinical Therapeutics, Meropenem, 03 medical and health sciences, Enterobacteriaceae, Fosfomycin, Sepsis, Internal medicine, medicine, Humans, Mortality, Aged, Pharmacology, Predictors, Colistin, Septic shock, business.industry, biochemical phenomena, metabolism, and nutrition, bacterial infections and mycoses, medicine.disease, mortality, Klebsiella Infections, Carbapenems, Thienamycins, Gentamicins, business
Abstract

Combination therapy including colistin and a carbapenem has been found to be associated with lower mortality in the treatment of bloodstream infections (BSI) due to KPC-producing Klebsiella pneumoniae when the isolates show a meropenem or imipenem MIC of, This study was funded by Planes Nacionales de I+D+i 2008-2011 and 2013-2016, Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Economía y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD12/0015/0010 and REIPI RD16/0016/0001; RD16/0016/0001; RD16/00167008) and cofinanced by European Development Regional Fund “A way to achieve Europe” and operative program Intelligent Growth 2014-2020.

Published
2017
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13. Efficacy of β-Lactam/β-Lactamase Inhibitor Combinations for the Treatment of Bloodstream Infection Due to Extended-Spectrum-β-Lactamase-Producing Enterobacteriaceae in Hematological Patients with Neutropenia

Author

F. Herrera, Jordi Carratalà, Guillermo Maestro de la Calle, Cristina Royo-Cebrecos, Carlos Cervera, Murat Akova, Maddalena Peghin, Georg Maschmeyer, Pilar Martín-Dávila, Mercè Gurguí, Jesús Rodríguez-Baño, Isabel Ruiz-Camps, Angela Cano, Yolanda Meije, Adriana Manzur, Teresa C. Sukiennik, Edson Abdala, Wanessa Trindade Clemente, Alison G. Freifeld, Cristian Tebe, Miguel Montejo, Thomas Gottlieb, Lucía Gómez, Carlota Gudiol, R. Alvarez, European Society of Clinical Microbiology and Infectious Diseases, Ministerio de Economía y Competitividad (España), Instituto de Salud Carlos III, European Commission, Red Española de Investigación en Patología Infecciosa, [Gudiol, Carlota] Univ Barcelona, Bellvitge Univ Hosp, IDIBELL, Infect Dis Dept, Barcelona, Spain, [Royo-Cebrecos, Cristina] Univ Barcelona, Bellvitge Univ Hosp, IDIBELL, Infect Dis Dept, Barcelona, Spain, [Carratala, Jordi] Univ Barcelona, Bellvitge Univ Hosp, IDIBELL, Infect Dis Dept, Barcelona, Spain, [Gudiol, Carlota] Duran & Reynals Hosp, ICO, Barcelona, Spain, [Abdala, Edson] Univ Sao Paulo, Fac Med, Inst Canc Estado Sao Paulo, Sao Paulo, Brazil, [Akova, Murat] Hacettepe Univ, Sch Med, Ankara, Turkey, [Alvarez, Rocio] Univ Seville, CSIC, Univ Hosp Virgen Rocio & Virgen Macarena, Inst Biomed Seville IBiS,Infect Dis Res Grp,Clin, Seville, Spain, [Maestro-de la Calle, Guillermo] Univ Complutense, Sch Med, Octubre Univ Hosp 12, Inst Invest Hosp Octubre 12 i 12,Infect Dis Unit, Madrid, Spain, [Cano, Angela] UCO, Reina Sofia Univ Hosp, IMIBIC, Cordoba, Spain, [Cervera, Carlos] Univ Alberta Hosp, Edmonton, AB, Canada, [Clemente, Wanessa T.] Univ Fed Minas Gerais, Hosp Clin, Digest Transplant Serv, Belo Horizonte, MG, Brazil, [Martin-Davila, Pilar] Hosp Ramon & Cajal, Infect Dis Dept, Madrid, Spain, [Freifeld, Alison] Univ Nebraska, Med Ctr, Internal Med Infect Dis Sect, Omaha, NE 68182 USA, [Gomez, Lucia] Univ Hosp Mutua Terrassa, Internal Med, Barcelona, Spain, [Gottlieb, Thomas] Concord Hosp, Dept Microbiol & Infect Dis, Concord, NSW, Australia, [Gurgui, Merce] Univ Autonoma Barcelona, Hosp Santa Creu & Sant Pau, Infect Dis Unit, Barcelona, Spain, [Gurgui, Merce] Univ Autonoma Barcelona, Inst Invest Biomed Sant Pau, Barcelona, Spain, [Herrera, Fabian] CEMIC, Dept Med, Infect Dis Sect, Buenos Aires, DF, Argentina, [Manzur, Adriana] Hosp Rawson, Infect Dis, San Juan, Argentina, [Maschmeyer, Georg] Charite, Med Sch, Acad Teaching Hosp, Dept Hematol Oncol & Palliat Care,Klinikum Ernst, Berlin, Germany, [Meije, Yolanda] Barcelona Hosp, SCIAS, Internal Med Dept, Infect Dis Unit, Barcelona, Spain, [Montejo, Miguel] Cruces Univ Hosp, Infect Dis Unit, Bilbao, Spain, [Peghin, Maddalena] Santa Maria Misericordia Univ Hosp, Infect Dis Div, Udine, Italy, [Rodriguez-Bano, Jesus] Univ Seville, Univ Hosp Virgen Macarena & Virgen Rocio IBiS, Dept Med, Clin Unit Infect Dis Microbiol & Prevent Med, Seville, Spain, [Ruiz-Camps, Isabel] Vall Hebron Univ Hosp, Infect Dis Dept, Barcelona, Spain, [Sukiennik, Teresa C.] Hosp Santa Casa Misericordia Porto Alegre, Porto Alegre, RS, Brazil, [Tebe, Cristian] Rovira & Virgili Univ, Inst Biomed Res Bellvitge, Stat Advisory Serv, Tarragona, Spain, [Gudiol, Carlota] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, [Royo-Cebrecos, Cristina] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, [Meije, Yolanda] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, [Montejo, Miguel] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, [Rodriguez-Bano, Jesus] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, [Ruiz-Camps, Isabel] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, [Carratala, Jordi] Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain, ESGBIS, ESGICH, Ministerio de Economia y Competitividad, Instituto de Salud Carlos III - European Development Regional Fund 'A way to achieve Europe' EDRF, Spanish Network for the Research in Infectious Diseases, COMBACTE-NET, COMBACTE-CARE, COMBACTE-MAGNET, Innovative Medicines Initiative (European Union), Innovative Medicines Initiative (EFPIA), Merck, Astellas, Novartis, Pfizer, MSD, Janssen, Astra-Zeneca, and İç Hastalıkları

Subjects
0301 basic medicine, Male, Definitive Therapy, Bacteremia, Escherichia-coli, Cohort Studies, chemistry.chemical_compound, Bloodstream infection, Case fatality rate, polycyclic compounds, beta-lactam/beta-lactamase inhibitors, Pharmacology (medical), Pharmacology & Pharmacy, Cancer, biology, Klebsiella-pneumoniae, Enterobacteriaceae Infections, Middle Aged, Enterobacteriaceae, Anti-Bacterial Agents, Risk-factors, Infectious Diseases, Beta-lactam/beta-lactamase inhibitors, Cohort, Lactam, Female, beta-Lactamase Inhibitors, Adult, medicine.medical_specialty, Neutropenia, 030106 microbiology, bloodstream infection, Outcomes, Clinical Therapeutics, beta-Lactams, Microbiology, beta-Lactamases, 03 medical and health sciences, β lactamase inhibitor, Piperacillin-tazobactam, Internal medicine, medicine, Humans, Mortality, Intensive care medicine, Pharmacology, business.industry, biochemical phenomena, metabolism, and nutrition, medicine.disease, biology.organism_classification, bacterial infections and mycoses, mortality, chemistry, ESBLs, Carbapenems, bacteria, Therapy, Bloodstream infections, business
Abstract

β-Lactam/β-lactamase inhibitors (BLBLIs) were compared to carbapenems in two cohorts of hematological neutropenic patients with extended-spectrum-β-lactamase (ESBL) bloodstream infection (BSI): the empirical therapy cohort (174 patients) and the definitive therapy cohort (251 patients). The 30-day case fatality rates and other secondary outcomes were similar in the two therapy groups of the two cohorts and also in the propensity-matched cohorts. BLBLIs might be carbapenem-sparing alternatives for the treatment of BSI due to ESBLs in these patients., We thank the ESGBIS and the ESGICH study groups for supporting the study. This study was supported by Ministerio de Economía y Competitividad, Instituto de Salud Carlos III—cofinanced by European Development Regional Fund “A way to achieve Europe” EDRF, Spanish Network for the Research in Infectious Diseases (REIPI RD12/0015).

Published
2017

14. Targeted simplification versus antipseudomonal broad-spectrum beta-lactams in patients with bloodstream infections due to Enterobacteriaceae (SIMPLIFY): a study protocol for a multicentre, open-label, phase III randomised, controlled, non-inferiority clinical trial

Author

López-Cortés, Luis Eduardo, Rosso-Fernández, Clara, Núñez-Núñez, María, Lavín-Alconero, Lucía, Bravo-Ferrer, José, Barriga, Ángel, Delgado, Mercedes, Lupión, Carmen, Retamar, Pilar, Rodríguez-Baño, Jesús, SIMPLIFY Study Group, [Eduardo Lopez-Cortes, Luis] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Nunez-Nunez, Maria] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Bravo-Ferrer, Jose] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Delgado, Mercedes] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Lupion, Carmen] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Retamar, Pilar] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Rodriguez-bano, Jesus] Univ Seville, Hosp Univ Virgen Macarena, Inst Biomed Sevilla IBiS,CSIC, Unidad Clin Enfermedades Infecciosas & Microbiol, Seville, Spain, [Rosso-Fernandez, Clara] Hosp Univ Virgen del Rocio, Unidad Invest Clin & Ensayos Clin UICEC HUVR, Seville, Spain, [Lavin-Alconero, Lucia] Hosp Univ Virgen del Rocio, Unidad Invest Clin & Ensayos Clin UICEC HUVR, Seville, Spain, [Barriga, Angel] Hosp Univ Virgen del Rocio, Unidad Invest Clin & Ensayos Clin UICEC HUVR, Seville, Spain, [Rosso-Fernandez, Clara] Hosp Virgen Macarena, Seville, Spain, [Lavin-Alconero, Lucia] Hosp Virgen Macarena, Seville, Spain, [Barriga, Angel] Hosp Virgen Macarena, Seville, Spain, [Rosso-Fernandez, Clara] Hosp Univ Virgen del Rocio, Farmacol Clin, Seville, Spain, [Nunez-Nunez, Maria] Hosp Univ Virgen Macarena, Unidad Clin Farm, Seville, Spain, Instituto de Salud Carlos III, integrated in the national I+D+i, European Union (ERDF/ESF), Spanish Clinical Research Network - ISCII, and Instituto de Salud Carlos III (ISCIII)

Subjects
Epidemiology, Antimicrobial treatment, Hospitalized-patients, bloodstream infection, Bacteremia, Urinary-tract-infections, Microbial Sensitivity Tests, beta-Lactams, Antibiotic de-escalation, Intraabdominal infections, Enterobacteriaceae, Pseudomonas, Humans, Stewardship, Pseudomonas Infections, broad-spectrum antibiotics, Acquired pneumonia, Drug Administration Routes, Enterobacteriaceae Infections, Double-blind, De-escalation, Severe sepsis, Anti-Bacterial Agents, antimicrobial stewardship, Treatment Outcome, Research Design
Abstract

Within the context of antimicrobial stewardship programmes, de-escalation of antimicrobial therapy is one of the proposed strategies for reducing the unnecessary use of broad-spectrum antibiotics (BSA). The empirical treatment of nosocomial and some healthcare-associated bloodstream infections (BSI) frequently includes a beta-lactam with antipseudomonal activity as monotherapy or in combination with other drugs, so there is a great opportunity to optimise the empirical therapy based on microbiological data. De-escalation is assumed as standard of care for experts in infectious diseases. However, it is less frequent than it would desirable. The SIMPLIFY trial is a multicentre, open-label, non-inferiority phase III randomised controlled clinical trial, designed as a pragmatic 'real-practice' trial. The aim of this trial is to demonstrate the non-inferiority of de-escalation from an empirical beta-lactam with antipseudomonal activity to a targeted narrow-spectrum antimicrobial in patients with BSI due to Enterobacteriaceae. The primary outcome is clinical cure, which will be assessed at the test of cure visit. It will be conducted at 19 Spanish public and university hospitals. Each participating centre has obtained the approval of the ethics review committee, the agreement of the directors of the institutions and authorisation from the Spanish Regulatory Agency (Agencia Española del Medicamento y Productos Sanitarios). Data will be presented at international conferences and published in peer-reviewed journals. Strategies to reduce the use of BSA should be a priority. Most of the studies that support de-escalation are observational, retrospective and heterogeneous. A recent Cochrane review stated that well-designed clinical trials should be conducted to assess the safety and efficacy of de-escalation. The European Union Clinical Trials Register: EudraCT number 2015-004219-19. Clinical trials.gov: NCT02795949. Protocol version: V.2.0, dated 16 May 2016. All items from the WHO Trial Registration Data Set are included in the registry.

Published
2017

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