Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004)

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of adding 125 mg or 250 mg doses of relebactam (MK-7655) to imipenem/cilastatin in adults 18 years or older with Complicated Intra-Abdominal Infection (cIAI). The primary hypothesis is that the relebactam + imipenem/cilastatin treatment regimen is non-inferior to treatment with imipenem/cilastatin alone with respect to the percentage of participants with a favorable clinical response at completion of intravenous (IV) study therapy.

Timeline

Start

2012-06-01

Primary completion

2014-08-12

Completion

2014-08-12

Outcome

Met primary endpoint

paper both were noninferior to IMI alone (95.2%; one-sided P < 0.001). PMID 27503659 ↗

registry Relebactam 250 mg With Imipenem/Cilastatin vs Placebo to Relebactam With Imipenem/Cilastatin; p < 0.001; Percentage Difference 1.1 (95% CI -6.2 to 8.6) NCT01506271 ↗

registry Relebactam 125 mg With Imipenem/Cilastatin vs Placebo to Relebactam With Imipenem/Cilastatin; p < 0.001; Percentage Difference 3.7 (95% CI -2.0 to 10.8) NCT01506271 ↗

Publications

• Results Lucasti C, Vasile L, Sandesc D, Venskutonis D, McLeroth P, Lala M, Rizk ML, Brown ML, Losada MC, Pedley A, Kartsonis NA, Paschke A. Phase 2, Dose-Ranging Study of Relebactam with Imipenem-Cilastatin in Subjects with Complicated Intra-abdominal Infection. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6234-43. doi: 10.1128/AAC.00633-16. Print 2016 Oct.

Drugs

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

Indications