Clinical Trial: A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

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 Summary: 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.
Sponsor: Replidyne

Current Primary Outcome: • Clinical response at test of cure. [ Time Frame: Day 8 to 12 ]

Original Primary Outcome: • Clinical response at test of cure.

Current Secondary Outcome:

Original Secondary Outcome: • Treatment emergent adverse event rates.

Information By: Replidyne

Dates:
Date Received: November 16, 2005
Date Started: December 2005
Date Completion: June 2008
Last Updated: May 30, 2008
Last Verified: May 2008