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

Suspected or Documented Gram-negative Bacterial Infection Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Gram-Negative Bacterial Infections
• Infections
• Suspected or Documented Gram-negative Bacterial Infection

• NCT number: NCT03230916
• Study type: Interventional
• Source: Merck Sharp & Dohme LLC
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2017
• Completion date: August 11, 2020