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All-cause mortality rates in adults with carbapenem-resistant Gram-negative bacterial infections: a comprehensive review of pathogen-focused, prospective, randomized, interventional clinical studies Lodise, Thomas P. Bassetti, Matteo Ferrer Roca, Ricard Naas, Thierry Niki, Yoshihito Paterson, David L. Zeitlinger, Markus Echols, Roger Institut Català de la Salut [Lodise TP] Department of Pharmacy Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA. [Bassetti M] Infectious Diseases Clinic, Department of Health Science, University of Genova and Policlinico San Martino IRCCS Hospital, Genova, Italy. [Ferrer R] Unitat de Cures Intensives, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Naas T] Hôpital Bicetre, Bacteriology-Hygiene Unit, APHP-, University Paris-Saclay, Paris, France. [Niki Y] Division of Clinical Infectious Diseases, Showa University, Tokyo, Japan. [Paterson DL] UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, Australia. [Zeitlinger M] Department of Clinical Pharmacology, Medical University, Vienna, Austria. [Echols R] Infectious Disease Drug Development Consulting, LLC, Easton, CT, USA Vall d'Hebron Barcelona Hospital Campus Malalties bacterianes gramnegatives - Mortalitat Medicaments antiinfecciosos Resistència als medicaments DISEASES::Bacterial Infections and Mycoses::Bacterial Infections::Gram-Negative Bacterial Infections Other subheadings::Other subheadings::Other subheadings::Other subheadings::/mortality CHEMICALS AND DRUGS::Organic Chemicals::Amides::Lactams::beta-Lactams::Carbapenems PHENOMENA AND PROCESSES::Microbiological Phenomena::Drug Resistance, Microbial ENFERMEDADES::infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias gramnegativas Otros calificadores::Otros calificadores::Otros calificadores::Otros calificadores::/mortalidad COMPUESTOS QUÍMICOS Y DROGAS::compuestos orgánicos::amidas::lactamas::beta-lactamas::carbapenems FENÓMENOS Y PROCESOS::fenómenos microbiológicos::farmacorresistencia microbiana Carbapenem resistance; Gram-negative; Cefiderocol Resistència als carbapenems; Gram-negatius; Cefiderocol Resistencia a carbapenémicos; Gram-negativo; Cefiderocol Introduction Pathogen-focused, randomized, controlled trials (PF-RCT) are important in the fight against carbapenem-resistant (CR) Gram-negative infections. Some recently approved antibiotics and older generic antibiotics with activity against CR Gram-negative bacteria were investigated in PF-RCTs in a variety of infections. Areas covered We searched Pubmed, Cochrane database and international clinical trial databases for PF-RCTs for the period between 2005 and 2020 and compared the study designs, patient populations, infection types, pathogens, and Day-28 all-cause mortality (ACM). Expert opinion PF-RCTs are particularly challenging to quantitatively assess and compare due to the heterogeneity in infection types, pathogens, CR mechanism, inclusion/exclusion criteria, and endpoints. Data interpretation is further complicated by lack of formal statistical analysis plans and/or non-inferiority design, and limited power across most PF-RCTs. The studies with new antibiotics (i.e. plazomicin, meropenem/vaborbactam, cefiderocol) ranked lower regarding feasibility, with relatively small sample sizes (analyzed: 37–118) versus the comparative effectiveness studies of older generic drugs (analyzed: 94–406). ACM ranged between 11.8% and 40% for CR Enterobacterales, 17.7% and 57.4% for CR Acinetobacter spp., and 20.0% and 30.8% for CR Pseudomonas aeruginosa. The information gathered must be considered carefully alongside the study limitations and caution should be exercised when making direct comparisons across trials. 2022-09-09T12:53:33Z 2022-09-09T12:53:33Z 2022-05 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Lodise TP, Bassetti M, Ferrer R, Naas T, Niki Y, Paterson DL, et al. All-cause mortality rates in adults with carbapenem-resistant Gram-negative bacterial infections: a comprehensive review of pathogen-focused, prospective, randomized, interventional clinical studies. Expert Rev Anti Infect Ther. 2022 May;20(5):707–19. 1744-8336 https://hdl.handle.net/11351/8120 10.1080/14787210.2022.2020099 34937518 000741842700001 http://hdl.handle.net/11351/8120 eng Expert Review of Anti-infective Therapy;20(5) https://doi.org/10.1080/14787210.2022.2020099 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Taylor & Francis Scientia