A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,372
Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
Clinical failure at 8 weeks post therapy
Time frame: At day 63
Clinical failure rates
Time frame: Through to day 35
Bacteriological eradication rates
Time frame: Through to day 63
Clinical failure rates for subjects with positive sputum culture at enrollment
Time frame: Through to day 63
Weekly mean symptom scores measured by the AECB SS
Time frame: Through to day 63
Rates and speed of symptom relief measured by the AECB SS
Time frame: Through to day 63
Clinical failure rates for subjects with co-administration of systemic corticosteroids (stratum 1)
Time frame: Through to day 63
Clinical failure rates for subjects without co-administration of systemic corticosteroids (stratum 2)
Time frame: Through to day 63
Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators
Time frame: Through to day 63
Improvement in symptoms burden measured by the AECB SS
Time frame: Through to day 63
Improvement in health related QoL measured by the SGRQ
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Unnamed facility
Les Escaldes, Andorra
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Quilmes, Buenos Aires, Argentina
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San Juan Bautista, Buenos Aires, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
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Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
Unnamed facility
Vicente López, Argentina
...and 210 more locations
Time frame: Through to day 63
spirometry tests will be compared between treatment groups
Time frame: Through to day 63
HCRU relat. to chronic bronchitis management incl. rescue med., concomitant med., therap. adjuncts, diagn. procedures, other medical care/medical staff requirement, hospitalizations (incl. ward and duration), and work productivity and activity impairment
Time frame: Through to day 63
Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea
Time frame: Through to day 63