1339. Results for the Supplemental Microbiological Modified Intent-to-Treat (SmMITT) Population of the RESTORE-IMI 1 Trial of Imipenem/Cilastatin/Relebactam (IMI/REL) vs. Imipenem/Cilastatin Plus Colistin (IMI+CST) in Patients with Imipenem-Nonsusceptible (NS) Bacterial Infections

ABSTRACT: Abstract

Background

Clinical trials of new antibacterial agents in patients with carbapenem-resistant infections are critical but challenging to conduct. One challenge is identifying the study population by microbiological (micro) criteria; patients need to be identified locally to initiate effective treatment rapidly, but data standardization requires central laboratory confirmation. REL is a novel β-lactamase inhibitor that can restore imipenem activity against many imipenem-NS Gram-negative pathogens. Here we compare a supplemental analysis population based on local microbiology data (SmMITT eligibility) with the primary analysis population (mMITT) from the RESTORE-IMI 1 trial (NCT02452047) of IMI/REL vs. IMI+CST.

Methods

Randomized, active-controlled, double-blind, ph

SUBMITTER: Kaye K 

PROVIDER: S-EPMC6254124 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature