A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
- Conditions
- Pneumonia
- Interventions
- Registration Number
- NCT00643227
- Lead Sponsor
- Pfizer
- Brief Summary
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 504
Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).
Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 clarithromycin extended release (ER) - 2 azithromycin SR -
- Primary Outcome Measures
Name Time Method sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 14-21)
- Secondary Outcome Measures
Name Time Method bacteriologic response (eradication rate) in the Bacteriological Per Protocol population TOC visit investigator assessment of clinical response in the Clinical Per Protocol population TOC visit sponsor assessment of clinical response by baseline pathogen End of Treatment (EOT) visit (Day 8-11) and TOC visit sponsor assessment of clinical response in the non-primary population EOT visit and TOC visit sponsor assessment of clinical responses in the Clinical Per Protocol population EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35) susceptibilities of baseline pathogens Study endpoint adverse events Continuous vital signs Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit physical examination Baseline clinical laboratory assessments (blood chemistry and hematology) Baseline and TOC visit
Trial Locations
- Locations (1)
Pfizer Investigational Site