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
1 other identifier
interventional
598
10 countries
59
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2003
Shorter than P25 for phase_3
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedJune 8, 2011
June 1, 2011
March 19, 2008
June 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
bacteriologic response in the Bacteriologic per Protocol population
Test of Cure (TOC) visit (Days 24-28)
Secondary Outcomes (6)
sponsor assessment of clinical response in the Bacteriologic per Protocol population
TOC visit
bacteriologic response for the remaining study populations
TOC visit
sponsor assessment of clinical response for the Bacteriologic per Protocol population
Long-Term Follow-Up (LTFU) visit (Days 38-45)
bacteriologic response for the Bacteriologic per Protocol population
TOC visit
summary of baseline susceptibilities
Study endpoint
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (59)
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
Omaha, Nebraska, 68144, United States
Pfizer Investigational Site
Hickory, North Carolina, 28601, United States
Pfizer Investigational Site
Eugene, Oregon, 97404, United States
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020, United States
Pfizer Investigational Site
Harleysville, Pennsylvania, 19438, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84109, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84121, United States
Pfizer Investigational Site
West Jordan, Utah, 84088, United States
Pfizer Investigational Site
Erembodegem, 9320, Belgium
Pfizer Investigational Site
Ghent, 9000, Belgium
Pfizer Investigational Site
Hasselt, 3500, Belgium
Pfizer Investigational Site
Nokia, 37100, Finland
Pfizer Investigational Site
Tampere, 33200, Finland
Pfizer Investigational Site
Courbevoie, 92 400, France
Pfizer Investigational Site
Gentilly, 94 250, France
Pfizer Investigational Site
Lille, 59000, France
Pfizer Investigational Site
Montpellier, 34 000, France
Pfizer Investigational Site
Rouen, 76 100, France
Pfizer Investigational Site
Villejuif, 94 800, France
Pfizer Investigational Site
Berlin, 10965, Germany
Pfizer Investigational Site
Berlin, 13593, Germany
Pfizer Investigational Site
Erkner, 15537, Germany
Pfizer Investigational Site
Ludwigshafen, 67069, Germany
Pfizer Investigational Site
Rüdersdorf, 15562, Germany
Pfizer Investigational Site
Tostedt, D-21255, Germany
Pfizer Investigational Site
Villingen-Schwenningen, 78054, Germany
Pfizer Investigational Site
Würzburg, 97070, Germany
Pfizer Investigational Site
Bangalore, Karnataka, 560 0344, India
Pfizer Investigational Site
Kochi, Kerala, 682 026, India
Pfizer Investigational Site
Hyderabad, 500 033, India
Pfizer Investigational Site
Pune, 411 004, India
Pfizer Investigational Site
Foligno, PG, 06034, Italy
Pfizer Investigational Site
Gualdo Tadino, PG, 06023, Italy
Pfizer Investigational Site
S.Eraclio-Foligno, PG, 06087, Italy
Pfizer Investigational Site
Spoleto, PG, 06049, Italy
Pfizer Investigational Site
Vocabolo Gaifana-Gualdo Tadino, PG, 06020, Italy
Pfizer Investigational Site
Ede (Gld), 6711 PS, Netherlands
Pfizer Investigational Site
Geldermalsen, 4191 AH, Netherlands
Pfizer Investigational Site
Huizen, 1271 BB, Netherlands
Pfizer Investigational Site
Elverum, 2402, Norway
Pfizer Investigational Site
Skedsmokorset, 2020, Norway
Pfizer Investigational Site
Bath, Avon, BA2 3HT, United Kingdom
Pfizer Investigational Site
Hastings, East Sussex, TN34 3EY, United Kingdom
Pfizer Investigational Site
Glenrothes, Fife, KY6 3LQ, United Kingdom
Pfizer Investigational Site
High Valleyfield, Fife, KY12 8SJ, United Kingdom
Pfizer Investigational Site
Tunbrige Wells, Kent, TN1 2EP, United Kingdom
Pfizer Investigational Site
Atherstone, Warwickshire, CV9 1EU, United Kingdom
Pfizer Investigational Site
Coventry, CV7 8LA, United Kingdom
Pfizer Investigational Site
Kent, TN1 2DX, United Kingdom
Pfizer Investigational Site
Kent, TN10 3ET, United Kingdom
Pfizer Investigational Site
Kent, TN11 9HL, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 26, 2008
Study Start
January 1, 2003
Study Completion
April 1, 2004
Last Updated
June 8, 2011
Record last verified: 2011-06