NCT04223752

Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

A Phase 1, Open-label, Non-comparative, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Ceftolozane/Tazobactam (MK-7625A) in Pediatric Participants With Nosocomial Pneumonia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 7 Days – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).

Conditions

• Nosocomial Pneumonia

Interventions

Type	Name	Description
DRUG	Ceftolozane/Tazobactam	Participants 12 to \<18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period. Participants \<12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g).

Timeline

• Start date: 2020-04-17
• Primary completion: 2024-09-14
• Completion: 2024-09-14
• First posted: 2020-01-10
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

24 sites across 9 countries: United States, Chile, Colombia, Estonia, Greece, Mexico, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study