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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644293

Purpose

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.

Condition	Intervention	Phase
Pharyngitis Tonsillitis	Drug: azithromycin (Zithromax) Drug: placebo Drug: azithromycin SR	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat Streptococcal Infections Tonsils and Adenoids

Drug Information available for: Azithromycin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

bacteriologic response in the Bacteriologic per Protocol population [ Time Frame: Test of Cure (TOC) visit (Days 24-28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

sponsor assessment of clinical response in the Bacteriologic per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
bacteriologic response for the remaining study populations [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
sponsor assessment of clinical response for the Bacteriologic per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Days 38-45) ] [ Designated as safety issue: No ]
bacteriologic response for the Bacteriologic per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment:	598
Study Start Date:	January 2003
Study Completion Date:	April 2004

Arms	Assigned Interventions
1: Experimental	Drug: azithromycin (Zithromax) azithromycin 500 mg tablet by mouth once daily for 3 days Drug: placebo placebo
2: Experimental	Drug: azithromycin SR azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose Drug: placebo placebo

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644293

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Locations

United States, Florida
Pfizer Investigational Site
CLEARWATER, Florida, United States, 33761
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83651
Pfizer Investigational Site
Boise, Idaho, United States, 83709
Pfizer Investigational Site
Boise, Idaho, United States, 83704
Pfizer Investigational Site
Boise, Idaho, United States, 83706
Pfizer Investigational Site
Boise, Idaho, United States, 83703
Pfizer Investigational Site
Meridian, Idaho, United States, 83642
Pfizer Investigational Site
NAMPA, Idaho, United States, 83651
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68144
United States, North Carolina
Pfizer Investigational Site
HICKORY, North Carolina, United States, 28601
Pfizer Investigational Site
Hickory, North Carolina, United States, 28601
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Pfizer Investigational Site
Harleysville, Pennsylvania, United States, 19438
Pfizer Investigational Site
Bensalem, Pennsylvania, United States, 19020
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84121
Pfizer Investigational Site
West Jordan, Utah, United States, 84088
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84109
Belgium
Pfizer Investigational Site
Hasselt, Belgium, 3500
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Erembodegem, Belgium, 9320
Finland
Pfizer Investigational Site
Tampere, Finland, 33200
Pfizer Investigational Site
Nokia, Finland, 37100
France
Pfizer Investigational Site
Lille, France, 59000
Pfizer Investigational Site
Rouen, France, 76 100
Pfizer Investigational Site
Gentilly, France, 94 250
Pfizer Investigational Site
Courbevoie, France, 92 400
Pfizer Investigational Site
Villejuif, France, 94 800
Pfizer Investigational Site
Montpellier, France, 34 000
Germany
Pfizer Investigational Site
Berlin, Germany, 10965
Pfizer Investigational Site
Villingen-Schwenningen, Germany, 78054
Pfizer Investigational Site
Ruedersdorf, Germany, 15562
Pfizer Investigational Site
Tostedt, Germany, D-21255
Pfizer Investigational Site
Ludwigshafen, Germany, 67069
Pfizer Investigational Site
Wuerzburg, Germany, 97070
Pfizer Investigational Site
Erkner, Germany, 15537
Pfizer Investigational Site
Berlin, Germany, 13593
India
Pfizer Investigational Site
Pune, India, 411 004
Pfizer Investigational Site
Hyderabad, India, 500 033
India, Karnataka
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 0344
India, Kerala
Pfizer Investigational Site
Kochi, Kerala, India, 682 026
Italy, PG
Pfizer Investigational Site
S.Eraclio-Foligno, PG, Italy, 06087
Pfizer Investigational Site
Vocabolo Gaifana-Gualdo Tadino, PG, Italy, 06020
Pfizer Investigational Site
Spoleto, PG, Italy, 06049
Pfizer Investigational Site
Foligno, PG, Italy, 06034
Pfizer Investigational Site
Gualdo Tadino, PG, Italy, 06023
Netherlands
Pfizer Investigational Site
Huizen, Netherlands, 1271 BB
Pfizer Investigational Site
Ede (Gld), Netherlands, 6711 PS
Pfizer Investigational Site
Geldermalsen, Netherlands, 4191 AH
Norway
Pfizer Investigational Site
Elverum, Norway, 2402
Pfizer Investigational Site
Skedsmokorset, Norway, 2020
United Kingdom
Pfizer Investigational Site
Kent, United Kingdom, TN1 2DX
Pfizer Investigational Site
Coventry, United Kingdom, CV7 8LA
Pfizer Investigational Site
Kent, United Kingdom, TN10 3ET
Pfizer Investigational Site
Kent, United Kingdom, TN11 9HL
United Kingdom, Avon
Pfizer Investigational Site
Bath, Avon, United Kingdom, BA2 3HT
United Kingdom, East Sussex
Pfizer Investigational Site
Hastings, East Sussex, United Kingdom, TN34 3EY
United Kingdom, Fife
Pfizer Investigational Site
High Valleyfield, Fife, United Kingdom, KY12 8SJ
Pfizer Investigational Site
Glenrothes, Fife, United Kingdom, KY6 3LQ
United Kingdom, Kent
Pfizer Investigational Site
Tunbrige Wells, Kent, United Kingdom, TN1 2EP
United Kingdom, Warwickshire
Pfizer Investigational Site
Atherstone, Warwickshire, United Kingdom, CV9 1EU

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Group )
Study ID Numbers:	A0661119
Study First Received:	March 19, 2008
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00644293 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses

Azithromycin
Tonsillitis
Stomatognathic Diseases
Pharyngitis
Pharyngeal Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009