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
Completed · Phase 3 · Has a placebo group
Conditions studied: Pneumonia
In brief
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.
Key facts
- Study ID
- NCT00643734
- Run by
- Pfizer
- People needed
- 468
- Starts
- 2003-04-01
- Expected to finish
- 2004-04-01
- Last updated by the study team
- 2008-03-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Phoenix, Arizona, United States
- Pfizer Investigational Site — San Luis Obispo, California, United States
- Pfizer Investigational Site — San Mateo, California, United States
- Pfizer Investigational Site — Highlands Ranch, Colorado, United States
- Pfizer Investigational Site — Newark, Delaware, United States
- Pfizer Investigational Site — Kissimmee, Florida, United States
- Pfizer Investigational Site — Merrit Island, Florida, United States
- Pfizer Investigational Site — Evansville, Indiana, United States
- Pfizer Investigational Site — Evansville, Indiana, United States
- Pfizer Investigational Site — Indianapolis, Indiana, United States
- Pfizer Investigational Site — Dubuque, Iowa, United States
- Pfizer Investigational Site — Pratt, Kansas, United States
- Pfizer Investigational Site — Madisonville, Kentucky, United States
- Pfizer Investigational Site — Cumberland, Maryland, United States
- Pfizer Investigational Site — Kalamazoo, Michigan, United States
- Pfizer Investigational Site — Olive Branch, Mississippi, United States
- Pfizer Investigational Site — Elkhorn, Nebraska, United States
- Pfizer Investigational Site — Omaha, Nebraska, United States
- Pfizer Investigational Site — Rio Rancho, New Mexico, United States
- Pfizer Investigational Site — Charlotte, North Carolina, United States
- Pfizer Investigational Site — Charlotte, North Carolina, United States
- Pfizer Investigational Site — Charlotte, North Carolina, United States
- Pfizer Investigational Site — Hickory, North Carolina, United States
- Pfizer Investigational Site — Yukon, Oklahoma, United States
- Pfizer Investigational Site — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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