drugset / Trial / NCT01069900
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |