NCT01069900

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intraabdominal Infections

Interventions

Type	Name	Description
DRUG	Moxifloxacin (Avelox, BAY12-8039)	For subjects 12 to less than (\<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to \< 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to \< 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.
DRUG	Ertapenem	For subjects 13 to \<18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to \< 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.
DRUG	Amoxicillin/Clavulanate	Subjects 2 years to \< 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).
DRUG	Moxifloxacin placebo	Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.
DRUG	Ertapenem placebo	Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.
DRUG	Amoxicillin/Clavulanate placebo	Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.

Timeline

• Start date: 2010-07-21
• Primary completion: 2015-01-21
• Completion: 2015-01-21
• First posted: 2010-02-17
• Last updated: 2018-03-20
• Results posted: 2015-12-08

Locations

39 sites across 16 countries: United States, Argentina, Bulgaria, Canada, Chile, Czechia, Germany, Greece, Hungary, Latvia, Lithuania, Mexico, Peru, Romania, Russia, Ukraine