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

Phase 2 Completed 94 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2018-04-03
Primary completion: 2020-03-16
Completion: 2020-03-16

Publications

Results Jackson CA, Newland J, Dementieva N, Lonchar J, Su FH, Huntington JA, Bensaci M, Popejoy MW, Johnson MG, De Anda C, Rhee EG, Bruno CJ. Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem From a Phase 2, Randomized Clinical Trial in Pediatric Participants With Complicated Intra-abdominal Infection. Pediatr Infect Dis J. 2023 Jul 1;42(7):557-563. doi: 10.1097/INF.0000000000003911. Epub 2023 Mar 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftolozane	Small molecule	20 mg/kg	Intravenous
Comparator	Meropenem	Small molecule	20 mg/kg	Intravenous
Subject	Metronidazole	Small molecule	7.5 mg/kg	Intravenous
Subject	Metronidazole	Small molecule	10 mg/kg	Intravenous
Subject	Tazobactam	Small molecule	10 mg/kg	Intravenous

Indications

No indication recorded.