Comparison of Treatment Outcomes between Analysis Populations in the RESTORE-IMI 1 Phase 3 Trial of Imipenem-Cilastatin-Relebactam versus Colistin plus Imipenem-Cilastatin in Patients with Imipenem-Nonsusceptible Bacterial Infections.
Adult
Age Factors
Aged
Aged, 80 and over
Anti-Bacterial Agents
/ therapeutic use
Azabicyclo Compounds
/ therapeutic use
Cilastatin, Imipenem Drug Combination
/ therapeutic use
Colistin
/ therapeutic use
Drug Resistance, Multiple, Bacterial
/ drug effects
Endpoint Determination
Female
Gram-Negative Bacterial Infections
/ drug therapy
Humans
Imipenem
/ pharmacology
Kidney
/ physiopathology
Male
Microbial Sensitivity Tests
Middle Aged
Sex Factors
Treatment Outcome
Young Adult
beta-Lactamase Inhibitors
/ pharmacology
carbapenem resistant
local microbiology data
supplemental analysis population
β-lactamase inhibitor
Journal
Antimicrobial agents and chemotherapy
ISSN: 1098-6596
Titre abrégé: Antimicrob Agents Chemother
Pays: United States
ID NLM: 0315061
Informations de publication
Date de publication:
21 04 2020
21 04 2020
Historique:
received:
04
11
2019
accepted:
13
02
2020
pubmed:
26
2
2020
medline:
7
4
2021
entrez:
26
2
2020
Statut:
epublish
Résumé
The RESTORE-IMI 1 phase 3 trial demonstrated the efficacy and safety of imipenem-cilastatin (IMI) combined with relebactam (REL) for treating imipenem-nonsusceptible infections. The objective of this analysis was to compare the outcomes among patients meeting eligibility requirements based on central laboratory susceptibility versus local laboratory susceptibility. Patients with serious infections caused by imipenem-nonsusceptible, colistin-susceptible, and imipenem-REL-susceptible pathogens were randomized 2:1 to IMI-REL plus placebo or colistin plus IMI for 5 to 21 days. The primary endpoint was a favorable overall response. Key endpoints included the clinical response and all-cause mortality. We compared outcomes between the primary microbiological modified intent-to-treat (mMITT) population, where eligibility was based on central laboratory susceptibility testing, and the supplemental mMITT (SmMITT) population, where eligibility was based on local, site-level testing. The SmMITT (
Identifiants
pubmed: 32094127
pii: AAC.02203-19
doi: 10.1128/AAC.02203-19
pmc: PMC7179630
pii:
doi:
Substances chimiques
Anti-Bacterial Agents
0
Azabicyclo Compounds
0
beta-Lactamase Inhibitors
0
Imipenem
71OTZ9ZE0A
Cilastatin, Imipenem Drug Combination
92309-29-0
relebactam
Y1MYA2UHFL
Colistin
Z67X93HJG1
Banques de données
ClinicalTrials.gov
['NCT02452047']
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NIAID NIH HHS
ID : R01 AI119446
Pays : United States
Informations de copyright
Copyright © 2020 American Society for Microbiology.
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