A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis
- Registration Number
- NCT00644449
- Lead Sponsor
- Pfizer
- Brief Summary
This study was performed to confirm that a single 2.0-g dose of azithromycin SR is at least as effective as 7 days of levofloxacin 500 mg/day in adults with acute exacerbation of chronic bronchitis Secondary objectives: To assess safety and the bacteriologic efficacy of both treatment regimens
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
Adult patients with a history of chronic bronchitis (i.e., chronic cough and sputum production on most days for 3 consecutive months for more than 2 years) and current evidence of an acute bacterial exacerbation of their disease, as demonstrated by production of purulent sputum and the presence of at lest 2 of the following signs and symptoms, were included: increased sputum production, increased dypsnea, increased cough, or increased sputum purulence.
Key exclusion criteria were treatment with any systemic antibiotic within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; a chest radiograph consistent with pneumonia; and previously diagnosed conditions which tend to mimic or complicate the course and evaluation of the infectious process (e.g., bronchiectasis, lung abscess or empyema, active TB, pulmonary malignancy, cystic fibrosis).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo - 2 placebo - 2 levofloxacin -
- Primary Outcome Measures
Name Time Method sponsor assessment of clinical response in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 14-21)
- Secondary Outcome Measures
Name Time Method sponsor assessment of clinical response in the remaining study populations TOC visit sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population EOT visit and TOC visit investigator assessment of clinical response in the Clinical Per Protocol population TOC visit bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population TOC visit sponsor assessment of clinical response in the Clinical Per Protocol population End of Treatment (EOT) visit (Day 8-11) Summary of baseline susceptibilities Study Endpoint adverse events Continuous clinical laboratory tests Baseline and EOT visit
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇻🇪Caracas, Venezuela