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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

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ClinicalTrials.gov Identifier: NCT00644293
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pharyngitis Tonsillitis Drug: azithromycin (Zithromax) Drug: placebo Drug: azithromycin SR Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 598 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2003
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. bacteriologic response in the Bacteriologic per Protocol population [ Time Frame: Test of Cure (TOC) visit (Days 24-28) ]

Secondary Outcome Measures :
  1. sponsor assessment of clinical response in the Bacteriologic per Protocol population [ Time Frame: TOC visit ]
  2. bacteriologic response for the remaining study populations [ Time Frame: TOC visit ]
  3. sponsor assessment of clinical response for the Bacteriologic per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Days 38-45) ]
  4. bacteriologic response for the Bacteriologic per Protocol population [ Time Frame: TOC visit ]
  5. summary of baseline susceptibilities [ Time Frame: Study endpoint ]
  6. adverse events [ Time Frame: Continuous ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644293


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

Additional Information:
Responsible Party: Director, Clinical Trial Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644293     History of Changes
Other Study ID Numbers: A0661119
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents