Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

Summary

This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) \[IMI/REL, MK-7655A\] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.

Timeline

Start

2018-09-18

Primary completion

2022-07-12

Completion

2022-07-12

Outcome

Met primary endpoint

paper IMI/REL was noninferior to PIP/TAZ for 28-day ACM (11.2% vs 5.9%; adjusted difference [95% confidence interval]: 5.2% [-1.5 to 12.4]). PMID 39674398 ↗

paper IMI/REL met noninferiority criteria vs PIP/TAZ for 28-day ACM, and PMID 39674398 ↗

Publications

• Results Li J, Wei F, Xiang P, Tang Z, Ding L, Chen LF, Losada M, Iamboliyska Z, Sun F, Zhu M, Guo X, Du X, Chen C, Bruno C, Koseoglu S, Young K, Zhou M, Qu J. A phase III, randomized, controlled noninferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) vs piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Int J Infect Dis. 2025 Apr;153:107357. doi: 10.1016/j.ijid.2024.107357. Epub 2024 Dec 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cilastatin	Small molecule	500 mg	Intravenous
Subject	IMIPENEM ANHYDROUS	Small molecule	500 mg	Intravenous
Comparator	Piperacillin	Small molecule	4000 mg	Intravenous
Subject	Relebactam	Small molecule	250 mg	Intravenous
Comparator	Tazobactam	Small molecule	500 mg	Intravenous
Background	Linezolid	Other / unclassified	600 mg	Intravenous

Indications