Colistin Monotherapy versus Combination Therapy for Carbapenem-Resistant Organisms.


Journal

NEJM evidence
ISSN: 2766-5526
Titre abrégé: NEJM Evid
Pays: United States
ID NLM: 9918317485806676

Informations de publication

Date de publication:
Jan 2023
Historique:
medline: 4 8 2023
pubmed: 4 8 2023
entrez: 4 8 2023
Statut: ppublish

Résumé

Pneumonia and bloodstream infections (BSI) due to extensively drug-resistant (XDR) The OVERCOME (Colistin Monotherapy versus Combination Therapy) trial was an international, randomized, double-blind, placebo-controlled trial. We randomly assigned participants to receive colistin (5 mg/kg once followed by 1.67 mg/kg every 8 hours) in combination with either meropenem (1000 mg every 8 hours) or matching placebo for the treatment of pneumonia and/or BSI caused by XDR A. Between 2012 and 2020, a total of 464 participants were randomly assigned to treatment, and 423 eligible patients comprised the modified intention-to-treat population. Combination therapy with colistin and meropenem was not superior to colistin monotherapy for the treatment of pneumonia or BSI caused by these pathogens. (Funded by the National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases protocol 10-0065; ClinicalTrials.gov number, NCT01597973.).

Sections du résumé

BACKGROUND BACKGROUND
Pneumonia and bloodstream infections (BSI) due to extensively drug-resistant (XDR)
METHODS METHODS
The OVERCOME (Colistin Monotherapy versus Combination Therapy) trial was an international, randomized, double-blind, placebo-controlled trial. We randomly assigned participants to receive colistin (5 mg/kg once followed by 1.67 mg/kg every 8 hours) in combination with either meropenem (1000 mg every 8 hours) or matching placebo for the treatment of pneumonia and/or BSI caused by XDR A.
RESULTS RESULTS
Between 2012 and 2020, a total of 464 participants were randomly assigned to treatment, and 423 eligible patients comprised the modified intention-to-treat population.
CONCLUSIONS CONCLUSIONS
Combination therapy with colistin and meropenem was not superior to colistin monotherapy for the treatment of pneumonia or BSI caused by these pathogens. (Funded by the National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases protocol 10-0065; ClinicalTrials.gov number, NCT01597973.).

Identifiants

pubmed: 37538951
doi: 10.1056/evidoa2200131
pmc: PMC10398788
mid: NIHMS1875033
doi:

Banques de données

ClinicalTrials.gov
['NCT01597973']

Types de publication

Journal Article

Langues

eng

Subventions

Organisme : NIAID NIH HHS
ID : HHSN272201600049C
Pays : United States

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Auteurs

Keith S Kaye (KS)

Division of Allergy, Immunology, and Infectious Diseases, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.

Dror Marchaim (D)

Division of Infectious Diseases, Assaf Harofeh Medical Center, Be'er Ya'akov, Israel.

Visanu Thamlikitkul (V)

Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Yehuda Carmeli (Y)

Laboratory for Microbiology and Infection Control, Tel Aviv University, Tel Aviv, Israel.

Cheng-Hsun Chiu (CH)

Division of Pediatric Infectious Diseases, Department of Pediatrics, Molecular Infectious Disease Research Center, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.

George Daikos (G)

School of Medicine, National and Kapodistrian University of Athens.

Sorabh Dhar (S)

Division of Infectious Diseases, Detroit Medical Center, Wayne State University, Detroit.

Emanuele Durante-Mangoni (E)

Internal Medicine, University of Campania "Luigi Vanvitelli" and AORN dei Colli-Monaldi Hospital, Napoli, Italy.

Achilles Gikas (A)

Department of Internal Medicine and Infectious Diseases, University Hospital of Heraklion, Irákleio, Greece.

Anastasia Kotanidou (A)

Medical School, National and Kapodistrian University of Athens.

Mical Paul (M)

Infectious Diseases Institute, Rambam Health Care Campus, Haifa, Israel.

Emmanuelle Roilides (E)

Infectious Diseases Unit, 3rd Department of Pediatrics, Aristotle University School of Health Sciences and Hippokration General Hospital, Thessaloniki, Greece.

Michael Rybak (M)

Anti-Infective Research Laboratory, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit.

Michael Samarkos (M)

First Department of Internal Medicine, Laiko General Hospital, Medical School, National and Kapodistrian University of Athens.

Matthew Sims (M)

Beaumont Health System, Royal Oak, MI.

Dora Tancheva (D)

Centre for Burns and Plastic Surgery, Pirogov Emergency Medicine Hospital, Sofia, Bulgaria.

Sotirios Tsiodras (S)

4th Department of Internal Medicine, Attikon University Hospital, University of Athens Medical School.

Daniel Kett (D)

University of Miami Hospital, Jackson Memorial Hospital.

Gopi Patel (G)

Division of Infectious Diseases, Mount Sinai Hospital, New York.

David Calfee (D)

Division of Infectious Disease, Weill Cornell Medicine, New York.

Leonard Leibovici (L)

Rabin Medical Center, Petah Tikva, Israel.

Laura Power (L)

University of Michigan, Ann Arbor.

Sylvia Munoz-Price (S)

Froedtert & the Medical College of Wisconsin, Milwaukee.

Kurt Stevenson (K)

The Ohio State University, Columbus, OH.

Laura Susick (L)

Department of Public Health Sciences, Henry Ford Health, Detroit.

Katie Latack (K)

Department of Public Health Sciences, Henry Ford Health, Detroit.

Jolene Daniel (J)

Division of Allergy, Immunology, and Infectious Diseases, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.

Christine Chiou (C)

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.

George W Divine (GW)

Department of Public Health Sciences, Henry Ford Health, Detroit.

Varduhi Ghazyaran (V)

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.

Jason M Pogue (JM)

Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor.

Classifications MeSH