NCT03230838

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (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) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

Conditions

• Complicated Urinary Tract Infection
• Pyelonephritis

Interventions

Type	Name	Description
DRUG	Ceftolozane/Tazobactam	12 to \<18 years of age: Ceftolozane 1 g/dose; Tazobactam 0.5 g/dose via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days. \<12 years of age: Ceftolozane 20 mg/kg with Tazobactam 10 mg/kg (not to exceed Ceftolozane 1 g and Tazobactam 0.5 g) via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days.
DRUG	Meropenem	Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.

Timeline

• Start date: 2018-04-26
• Primary completion: 2020-12-03
• Completion: 2020-12-03
• First posted: 2017-07-26
• Last updated: 2023-05-06
• Results posted: 2021-12-01

Locations

52 sites across 10 countries: United States, Greece, Hungary, Mexico, Poland, Romania, Russia, South Africa, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study