IMI/REL FDC

DRUG2 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Hospital-Acquired Bacterial PneumoniaSuspected or Documented Gram-negative Bacterial InfectionVentilator-Associated Bacterial Pneumonia

Phase 1

A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

CompletedNCT03230916

Merck Sharp & Dohme LLCSuspected or Documented Gram-negative Bacterial Infection

Start: 2017-11-06End: 2020-08-11Updated: 2024-02-06

Phase 3

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

CompletedNCT03583333

Merck Sharp & Dohme LLCHospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia

Start: 2018-09-18End: 2022-07-12Updated: 2025-01-29

Related Papers

P-1184. Efficacy and Safety of Imipenem/Cilastatin/Relebactam (IMI/REL) in Treating Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia: A Systematic Literature Review of Randomized Control Trials

Open Forum Infectious Diseases2026-01-01

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).

2024-12-121 citations

2519. 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

Open Forum Infectious Diseases2023-11-271 citations

Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Children with Confirmed or Suspected Gram‐Negative Bacterial Infections: A Phase 1b, Open‐Label, Single‐Dose Clinical Trial

The Journal of Clinical Pharmacology2023-08-1010 citations

1159. Pharmacokinetics, Safety, and Tolerability of Imipenem/Cilastatin/Relebactam in Pediatric Participants With Confirmed or Suspected Gram-negative Bacterial Infections: A Phase 1b, Open-label, Single-Dose Clinical Trial

Open Forum Infectious Diseases2021-11-014 citations