A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Pharyngitis, Tonsillitis

In brief

To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

Key facts

Study ID

NCT00644293

Run by

Pfizer

People needed

598

Starts

2003-01-01

Expected to finish

2004-04-01

Last updated by the study team

2011-06-08

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS

You may not qualify if…

• Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.

Where it is running

• 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 — Omaha, Nebraska, United States
• Pfizer Investigational Site — Hickory, North Carolina, United States
• Pfizer Investigational Site — Eugene, Oregon, United States
• Pfizer Investigational Site — Bensalem, Pennsylvania, United States
• Pfizer Investigational Site — Harleysville, Pennsylvania, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — West Jordan, Utah, United States
• Pfizer Investigational Site — Erembodegem, Belgium
• Pfizer Investigational Site — Ghent, Belgium
• Pfizer Investigational Site — Hasselt, Belgium
• Pfizer Investigational Site — Nokia, Finland
• Pfizer Investigational Site — Tampere, Finland
• Pfizer Investigational Site — Courbevoie, France
• Pfizer Investigational Site — Gentilly, France
• Pfizer Investigational Site — Lille, France
• Pfizer Investigational Site — Montpellier, France
• Pfizer Investigational Site — Clearwater, Florida, United States

Full record on ClinicalTrials.gov

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