NCT03969901

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

A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suspected or Documented Gram-negative Bacterial Infection

Interventions

Type	Name	Description
DRUG	IMI/REL	Age-based dosing: * 12 to \<18 years, IMI 500 and REL 250 mg, IV infusion every 6 hours * 6 to \<12 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours * 2 to \<6 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours * 3 months to \<2 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours * Birth to \<3 months, IMI 15 and REL 7.5 mg/kg, IV infusion every 8 hours NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention.
DRUG	Active Control	All active control medications will be chosen from a list of acceptable approved agents for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines. NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention. All oral switch medications will be chosen from a list of acceptable approved agents.
DRUG	Oral Switch	All oral switch medications will be investigator's choice from a list of acceptable approved agents for infection types cIAI, and cUTI and will be given per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines. Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention.

Timeline

• Start date: 2019-10-08
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2019-05-31
• Last updated: 2026-02-05
• Results posted: 2025-05-13

Locations

67 sites across 18 countries: United States, Bulgaria, Chile, Colombia, Estonia, France, Greece, Hungary, Israel, Mexico, Norway, Philippines, Poland, Russia, South Africa, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study