drugset / Trial / NCT01069900

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

NCT01069900

Phase 3 Completed 458 enrolled Bayer
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to \<18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.

Timeline

Start
2010-07-21
Primary completion
2015-01-21
Completion
2015-01-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 22.5 mg Oral
Comparator Clavulanate Unknown 3.2 mg/kg Oral
Comparator Ertapenem Small molecule 15 mg/kg Intravenous
Comparator Ertapenem Small molecule 1 g Intravenous
Subject Moxifloxacin Small molecule 4 mg/kg Intravenous
Subject Moxifloxacin Small molecule 5 mg/kg Intravenous
Subject Moxifloxacin Small molecule 6 mg/kg Intravenous
Subject Moxifloxacin Small molecule 400 mg Intravenous