Belén Gutiérrez-Gutiérrez1, Robert A Bonomo2, Yehuda Carmeli3, David L Paterson4, Benito Almirante5, Luis Martínez-Martínez6, Antonio Oliver7, Esther Calbo8, Carmen Peña9, Murat Akova10, Johann Pitout11, Julia Origüen12, Vicente Pintado13, Elisa García-Vázquez14, Oriol Gasch15, Axel Hamprecht16, Nuria Prim17, Mario Tumbarello18, German Bou19, Pierluigi Viale20, Evelina Tacconelli21, Manel Almela22, Federico Pérez23, Helen Giamarellou24, José Miguel Cisneros1, Mitchell J Schwaber3, Mario Venditti25, Warren Lowman26, Joaquín Bermejo27, Po-Ren Hsueh28, Marta Mora-Rillo29, Irene Gracia-Ahulfinger30, Alvaro Pascual31, Jesús Rodríguez-Baño32. 1. Unidad Clínica Intercentros de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospitales Universitarios Virgen Macarena y Virgen del Rocío, Seville, Spain. 2. Research Service, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA Departments of Medicine, Pharmacology, Biochemistry, Molecular Biology and Microbiology, Case Western Reserve University School of Medicine, Cleveland, OH, USA. 3. Division of Epidemiology and Preventive Medicine, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, and National Center for Infection Control, Israel Ministry of Health, Tel Aviv, Israel. 4. University of Queensland Centre for Clinical Research, The University of Queensland, Herston, Brisbane, Australia. 5. Hospital Universitari Vall d'Hebrón, Barcelona, Spain. 6. Hospital Universitario Marqués de Valdecilla-IDIVAL, Santander, Spain, and Departamento de Biología Molecular, Universidad de Cantabria, Santander, Spain. 7. Hospital Universitario Son Espases, Instituto de Investigación Sanitaria de Palma (IdISPa), Palma de Mallorca, Spain. 8. Hospital Universitari Mútua de Terrassa, Barcelona, Spain. 9. Hospital Universitari de Bellvitge, Barcelona, Spain. 10. Hacettepe University School of Medicine, Ankara, Turkey. 11. Department of Medicine, University of Calgary, Calgary, Canada. 12. Hospital Universitario 12 de Octubre, Madrid, Spain. 13. Department of Infectious Diseases, Hospital Ramón y Cajal-IRYCIS, Madrid, Spain. 14. Hospital Universitario Virgen de la Arrixaca, Murcia, Spain. 15. Corporacio Sanitaria Parc Taulí, Sabadell, Barcelona, Spain. 16. Institut für Mikrobiologie, Immunologie und Hygiene, Universitätsklinikum Köln, Cologne, Germany. 17. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 18. Catholic University of the Sacred Heart, Rome, Italy. 19. Complejo Hospitalario Universitario A Coruña, A Coruña, Spain. 20. Teaching Hospital Policlinico S. Orsola Malpighi, Bologna, Italy. 21. Universitätsklinikum Tübingen, Tübingen, Germany. 22. Hospital Clinic, Barcelona, Spain. 23. Research Service, Louis Stokes Cleveland Department of Veterans Affairs Medical Center, Cleveland, OH, USA. 24. Hygeia General Hospital, Athens, Greece. 25. Policlinico Umberto I, University of Rome La Sapienza, Rome, Italy. 26. Wits Donald Gordon Medical Centre, Johannesburg, South Africa. 27. Hospital Español, Rosario, Argentina. 28. National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. 29. Hospital Universitario La Paz-IdiPAZ, Madrid, Spain. 30. Hospital Universitario Reina Sofia-IMIBIC-UCO, Córdoba, Spain. 31. Unidad Clínica Intercentros de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospitales Universitarios Virgen Macarena y Virgen del Rocío, Seville, Spain Departamento de Microbiología, Universidad de Sevilla, Seville, Spain. 32. Unidad Clínica Intercentros de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospitales Universitarios Virgen Macarena y Virgen del Rocío, Seville, Spain Departamento de Medicina, Universidad de Sevilla, Seville, Spain jesusrb@us.es.
Abstract
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.
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.
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