Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)

Phase 2 Completed 302 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of MK-7655 (relebactam) to imipenem/cilastatin in adults 18 years or older with complicated urinary tract infection (cUTI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to imipenem/cilastatin with respect to the proportion of participants with a favorable microbiological response at completion of intravenous (IV) study therapy.

Timeline

Start: 2012-05-16
Primary completion: 2015-07-28
Completion: 2015-07-28

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Relebactam 125 mg With Imipenem/Cilastatin vs Relebactam Placebo With Imipenem/Cilastatin; p < 0.001; Percent Difference -0.1 (95% CI -6.4 to 5.9) NCT01505634 ↗

paper confirming non-inferiority of both imipenem/cilastatin + relebactam doses to imipenem/cilastatin alone. PMID 28575389 ↗

release “investigational beta-lactamase inhibitor, in combination with imipenem/cilastatin (an approved carbapenem antibiotic), in patients with complicated urinary tract infections, met its primary endpoint.” merck.com ↗

Publications

Results Sims M, Mariyanovski V, McLeroth P, Akers W, Lee YC, Brown ML, Du J, Pedley A, Kartsonis NA, Paschke A. Prospective, randomized, double-blind, Phase 2 dose-ranging study comparing efficacy and safety of imipenem/cilastatin plus relebactam with imipenem/cilastatin alone in patients with complicated urinary tract infections. J Antimicrob Chemother. 2017 Sep 1;72(9):2616-2626. doi: 10.1093/jac/dkx139.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Relebactam	Small molecule	125 mg	Intravenous
Subject	Relebactam	Small molecule	250 mg	Intravenous
Subject	imipenem/cilastatin	Unknown	500 mg	Intravenous
Background	Ciprofloxacin	Small molecule	500 mg	Oral