CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 47 enrolled
Drug / intervention
IMI/REL FDCdrug
Likely dose
IMI/REL FDC 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03230916
NCT03230916Phase 1Completed
CompareCT.gov

A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Infections

Merck Sharp & Dohme LLC·interventional·Posted Jul 27, 2017·Updated Feb 6, 2024

In Brief

A Phase 1 clinical trial evaluating IMI/REL FDC for Suspected or Documented Gram-negative Bacterial Infection. Completed, enrolled 47 participants across 33 sites in 8 countries.

Detailed Summary

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuspected or Documented Gram-negative Bacterial Infection
CountriesBulgaria, Colombia, Greece, Norway, Poland, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJul 27, 2017
Enrollment StartNov 6, 2017
Primary CompletionJul 28, 2020
Study CompletionAug 11, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.9 years ago

Interventions

IMI/REL FDCdrug

IMI/REL is supplied as a single fixed dose combination (FDC) vial; which is administered at a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).