A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients
- Conditions
- Pneumonia
- Interventions
- Registration Number
- NCT00643734
- Lead Sponsor
- Pfizer
- Brief Summary
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 468
Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 azithromycin sustained release - 1 placebo - 2 placebo - 2 levofloxacin -
- Primary Outcome Measures
Name Time Method sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population Test of Cure (TOC) visit (Days 14-21)
- Secondary Outcome Measures
Name Time Method laboratory abnormalities Baseline and TOC visit sponsor assessment of clinical response (cure or failure) in the remaining study populations EOT visit and 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 (cure or failure) in the Clinical Per Protocol population TOC visit sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population Long-Term Follow-Up (LTFU) visit (Days 28-35) bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population TOC visit summary of baseline susceptibilities Study endpoint adverse events Continuous
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇷🇺Smolensk, Russian Federation