Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)

Summary

The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.

Timeline

Start

2019-10-08

Primary completion

2024-05-07

Completion

2024-05-07

Publications

• Bradley JS, Norice CT, Roilides E, Shevelev A, Jurkiewicz B, Piedrahita JA, Macias-Parra M, Monroy Colin VA, Dalgic N, Koseoglu S, Masih I, Nair P, Young K, Hilbert DW, Nieddu GT, Patel M, Huntington JA, Paschke A, Bruno CJ. Phase 2/3, Open-label, Randomized, Active-controlled Clinical Trial Evaluating the Safety and Efficacy of Imipenem/Cilastatin/Relebactam in Pediatric Patients From Birth to Less Than 18 Years With Gram-negative Bacterial Infections. Pediatr Infect Dis J. 2026 Jul 7. doi: 10.1097/INF.0000000000005323. Online ahead of print.

Drugs

Indications