At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients With Complicated Intra-Abdominal Infection [cIAI]
In Brief
A Phase 2 clinical trial evaluating Relebactam 250 mg, Relebactam 125 mg, and 2 other interventions for Intra-abdominal Infections. Completed, enrolled 351 participants.
Detailed 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.
Study Details
Timeline
Interventions
Relebactam 250 mg IV every 6 hours for a minimum of 96 hours
Relebactam 125 mg IV every 6 hours for a minimum of 96 hours
A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval.
Placebo-matching infusion of IV normal saline (0.9%) once every 6 hours.