Status:
COMPLETED
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
Lead Sponsor:
Pfizer
Conditions:
Pneumonia
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 da...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00643227
Start Date
January 1 2003
End Date
March 1 2004
Last Update
March 26 2008
Active Locations (72)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35215
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35242
3
Pfizer Investigational Site
Haleyville, Alabama, United States, 35565
4
Pfizer Investigational Site
Montgomery, Alabama, United States, 36106