NCT03583333

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

A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hospital-Acquired Bacterial Pneumonia
• Ventilator-Associated Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	IMI/REL FDC	500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial
DRUG	PIP/TAZ FDC	4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial
DRUG	Linezolid	Open-label 600 mg Linezolid

Timeline

• Start date: 2018-09-18
• Primary completion: 2022-07-12
• Completion: 2022-07-12
• First posted: 2018-07-11
• Last updated: 2025-01-29
• Results posted: 2023-06-28

Locations

68 sites across 8 countries: Brazil, China, France, Mexico, Philippines, Romania, Russia, Ukraine

Regulatory

• FDA-regulated drug study