NCT03217136

MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem in Pediatric Subjects With Complicated Intra-Abdominal Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 7 Days – 17 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.

Conditions

• Complicated Intra-Abdominal Infection

Interventions

Type	Name	Description
DRUG	Ceftolozane/Tazobactam	Ceftolozane 20 mg/kg (maximum 1 g) and tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days.
DRUG	Metronidazole	Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants ≤ 28 days old, start with a loading dose of 15 mg/kg; then if ≤ 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if \> 2 kg are dosed 10 mg/kg every 8 hours.
DRUG	Meropenem	Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days.
DRUG	Placebo for Metronidazole	Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days.

Timeline

• Start date: 2018-04-03
• Primary completion: 2020-03-16
• Completion: 2020-03-16
• First posted: 2017-07-13
• Last updated: 2023-05-06
• Results posted: 2021-12-21

Locations

50 sites across 12 countries: United States, Brazil, Hungary, Lithuania, Malaysia, Mexico, Romania, Russia, South Africa, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study