drugset / Trial / NCT04223752

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

NCT04223752

Phase 1 Completed 41 enrolled Merck Sharp & Dohme LLC
Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start
2020-04-17
Primary completion
2024-09-14
Completion
2024-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftolozane Small molecule 40 mg/kg Intravenous
Subject Ceftolozane Small molecule 2 g Intravenous
Subject Tazobactam Small molecule 20 mg/kg Intravenous
Subject Tazobactam Small molecule 1 g Intravenous

Indications