A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients

Completed · Phase 3

Conditions studied: Pneumonia

In brief

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.

Key facts

Study ID: NCT00643227
Run by: Pfizer
People needed: 504
Starts: 2003-01-01
Expected to finish: 2004-03-01
Last updated by the study team: 2008-03-26

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

Pfizer Investigational Site — Birmingham, Alabama, United States
Pfizer Investigational Site — Haleyville, Alabama, United States
Pfizer Investigational Site — Montgomery, Alabama, United States
Pfizer Investigational Site — Montgomery, Alabama, United States
Pfizer Investigational Site — Tallassee, Alabama, United States
Pfizer Investigational Site — Mesa, Arizona, United States
Pfizer Investigational Site — Phoenix, Arizona, United States
Pfizer Investigational Site — Tempe, Arizona, United States
Pfizer Investigational Site — La Jolla, California, United States
Pfizer Investigational Site — San Diego, California, United States
Pfizer Investigational Site — Orlando, Florida, United States
Pfizer Investigational Site — Boise, Idaho, United States
Pfizer Investigational Site — Boise, Idaho, United States
Pfizer Investigational Site — Boise, Idaho, United States
Pfizer Investigational Site — Boise, Idaho, United States
Pfizer Investigational Site — Boise, Idaho, United States
Pfizer Investigational Site — Meridian, Idaho, United States
Pfizer Investigational Site — Nampa, Idaho, United States
Pfizer Investigational Site — Chalmette, Louisiana, United States
Pfizer Investigational Site — New Orleans, Louisiana, United States
Pfizer Investigational Site — New Orleans, Louisiana, United States
Pfizer Investigational Site — Butte, Montana, United States
Pfizer Investigational Site — Holmdel, New Jersey, United States
Pfizer Investigational Site — Clemmons, North Carolina, United States
Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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