Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

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

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.

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Principal Investigators

• Bayer Study Director · Bayer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-21

Primary Completion

2015-01-21

Completion

2015-01-21

Countries

• United States
• Argentina
• Bulgaria
• Canada
• Chile
• Czechia
• Germany
• Greece
• Hungary
• Latvia
• Lithuania
• Mexico
• Peru
• Romania
• Russia
• Ukraine

Study Locations