Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis
Overview
- Phase
- Phase 3
- Intervention
- Faropenem medoxomil
- Conditions
- Chronic Bronchitis
- Sponsor
- Replidyne
- Enrollment
- 491
- Locations
- 1
- Primary Endpoint
- • Clinical response at test of cure.
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
Brief Summary
Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (AECB) is the purpose of this clinical trial. The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB.
Detailed Description
This is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB. All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or non-pregnant female outpatients age greater than or equal 35 years with significant COPD (GOLD criteria I, IIA or IIB), chronic cough and sputum production and an acute exacerbation
Exclusion Criteria
- •Gold criteria III
Arms & Interventions
1
faropenem medoxomil
Intervention: Faropenem medoxomil
2
Intervention: placebo
Outcomes
Primary Outcomes
• Clinical response at test of cure.
Time Frame: Day 8 to 12