Clinical Trial: Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazo

Brief Summary: This study aims to compare treatment with imipenem/relebactam/cilastatin (IMI/REL) as a fixed-dose combination (FDC) with piperacillin/tazobactam (PIP/TAZ) FDC in participants with hospital-acquired and ventilator-associated bacterial pneumonia. The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ in the incidence rate of all-cause mortality.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Percentage of participants surviving at Day 28 [ Time Frame: Day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of participants with a favorable clinical response at early follow up visit [ Time Frame: Up to 16 days after end of therapy (up to Day 30) ]

Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: July 7, 2015
Date Started: November 24, 2015
Date Completion: May 31, 2019
Last Updated: May 10, 2017
Last Verified: May 2017