A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
- Registration Number
- NCT00643409
- Lead Sponsor
- Pfizer
- Brief Summary
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 541
Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.
Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.
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 for the Clinical per Protocol population Test of Cure (TOC) visit (Day 17-24)
- Secondary Outcome Measures
Name Time Method adverse events Continuous sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population EOT visit and TOC visit summary of baseline susceptibilities Study endpoint investigator assessment of clinical response for the Clinical per Protocol population TOC visit bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population TOC visit laboratory abnormalities during and post-treatment sponsor assessment of clinical response for the Clinical per Protocol population End of Treatment (EOT) visit (Day 11-13) sponsor assessment of clinical response for the remaining study populations EOT visit and TOC visit
Trial Locations
- Locations (1)
Pfizer Investigational Site