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

Condition(s) targeted: Pharyngitis; Tonsillitis

Intervention: azithromycin (Zithromax) (Drug); placebo (Drug); azithromycin SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: bacteriologic response in the Bacteriologic per Protocol population

Secondary outcome:

sponsor assessment of clinical response in the Bacteriologic per Protocol population

bacteriologic response for the remaining study populations

sponsor assessment of clinical response for the Bacteriologic per Protocol population

bacteriologic response for the Bacteriologic per Protocol population

summary of baseline susceptibilities

adverse events

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Pfizer Investigational Site, Hasselt 3500, Belgium

Pfizer Investigational Site, Gent 9000, Belgium

Pfizer Investigational Site, Erembodegem 9320, Belgium

Pfizer Investigational Site, Tampere 33200, Finland

Pfizer Investigational Site, Nokia 37100, Finland

Pfizer Investigational Site, Lille 59000, France

Pfizer Investigational Site, Rouen 76 100, France

Pfizer Investigational Site, Gentilly 94 250, France

Pfizer Investigational Site, Courbevoie 92 400, France

Pfizer Investigational Site, Villejuif 94 800, France

Pfizer Investigational Site, Montpellier 34 000, France

Pfizer Investigational Site, Berlin 10965, Germany

Pfizer Investigational Site, Villingen-Schwenningen 78054, Germany

Pfizer Investigational Site, Ruedersdorf 15562, Germany

Pfizer Investigational Site, Tostedt D-21255, Germany

Pfizer Investigational Site, Ludwigshafen 67069, Germany

Pfizer Investigational Site, Wuerzburg 97070, Germany

Pfizer Investigational Site, Erkner 15537, Germany

Pfizer Investigational Site, Berlin 13593, Germany

Pfizer Investigational Site, Pune 411 004, India

Pfizer Investigational Site, Hyderabad 500 033, India

Pfizer Investigational Site, Huizen 1271 BB, Netherlands

Pfizer Investigational Site, Ede (Gld) 6711 PS, Netherlands

Pfizer Investigational Site, Geldermalsen 4191 AH, Netherlands

Pfizer Investigational Site, Elverum 2402, Norway

Pfizer Investigational Site, Skedsmokorset 2020, Norway

Pfizer Investigational Site, Kent TN1 2DX, United Kingdom

Pfizer Investigational Site, Coventry CV7 8LA, United Kingdom

Pfizer Investigational Site, Kent TN10 3ET, United Kingdom

Pfizer Investigational Site, Kent TN11 9HL, United Kingdom

Pfizer Investigational Site, Bath, Avon BA2 3HT, United Kingdom

Pfizer Investigational Site, Hastings, East Sussex TN34 3EY, United Kingdom

Pfizer Investigational Site, High Valleyfield, Fife KY12 8SJ, United Kingdom

Pfizer Investigational Site, Glenrothes, Fife KY6 3LQ, United Kingdom

Pfizer Investigational Site, CLEARWATER, Florida 33761, United States

Pfizer Investigational Site, Clearwater, Florida 33761, United States

Pfizer Investigational Site, Boise, Idaho 83651, United States

Pfizer Investigational Site, Boise, Idaho 83703, United States

Pfizer Investigational Site, Boise, Idaho 83704, United States

Pfizer Investigational Site, Boise, Idaho 83706, United States

Pfizer Investigational Site, Boise, Idaho 83709, United States

Pfizer Investigational Site, Meridian, Idaho 83642, United States

Pfizer Investigational Site, NAMPA, Idaho 83651, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 0344, India

Pfizer Investigational Site, Tunbrige Wells, Kent TN1 2EP, United Kingdom

Pfizer Investigational Site, Kochi, Kerala 682 026, India

Pfizer Investigational Site, Omaha, Nebraska 68144, United States

Pfizer Investigational Site, HICKORY, North Carolina 28601, United States

Pfizer Investigational Site, Hickory, North Carolina 28601, United States

Pfizer Investigational Site, Eugene, Oregon 97404, United States

Pfizer Investigational Site, S.Eraclio-Foligno, PG 06087, Italy

Pfizer Investigational Site, Gualdo Tadino, PG 06023, Italy

Pfizer Investigational Site, Spoleto, PG 06049, Italy

Pfizer Investigational Site, Foligno, PG 06034, Italy

Pfizer Investigational Site, Vocabolo Gaifana-Gualdo Tadino, PG 06020, Italy

Pfizer Investigational Site, Harleysville, Pennsylvania 19438, United States

Pfizer Investigational Site, Bensalem, Pennsylvania 19020, United States

Pfizer Investigational Site, Salt Lake City, Utah 84121, United States

Pfizer Investigational Site, West Jordan, Utah 84088, United States

Pfizer Investigational Site, Salt Lake City, Utah 84109, United States

Pfizer Investigational Site, Atherstone, Warwickshire CV9 1EU, United Kingdom

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Ending date: April 2004
Last updated: March 26, 2008