Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT00643734
Start Date
April 1 2003
End Date
April 1 2004
Last Update
March 26 2008
Active Locations (65)
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1
Pfizer Investigational Site
Mesa, Arizona, United States, 85206
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85014
3
Pfizer Investigational Site
San Luis Obispo, California, United States, 93401
4
Pfizer Investigational Site
San Mateo, California, United States, 94403