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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
491
600 mg BID for 5 days
placebo tablets BID for 5 days
Multicenter
New Hope, Pennsylvania, United States
• Clinical response at test of cure.
Time frame: Day 8 to 12
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