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

June 3, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

598

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Erembodegem, Belgium, 9320
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Hasselt, Belgium, 3500
        • Pfizer Investigational Site
  • Finland
      • Nokia, Finland, 37100
        • Pfizer Investigational Site
      • Tampere, Finland, 33200
        • Pfizer Investigational Site
  • France
      • 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
        • Pfizer Investigational Site
  • Germany
      • 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
        • Pfizer Investigational Site
  • India
      • Hyderabad, India, 500 033
        • Pfizer Investigational Site
      • Pune, India, 411 004
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 0344
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Pfizer Investigational Site
  • Italy
    • PG
      • 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
        • Pfizer Investigational Site
  • Netherlands
      • Ede (Gld), Netherlands, 6711 PS
        • Pfizer Investigational Site
      • Geldermalsen, Netherlands, 4191 AH
        • Pfizer Investigational Site
      • Huizen, Netherlands, 1271 BB
        • Pfizer Investigational Site
  • Norway
      • Elverum, Norway, 2402
        • Pfizer Investigational Site
      • Skedsmokorset, Norway, 2020
        • Pfizer Investigational Site
  • United Kingdom
      • 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
        • Pfizer Investigational Site
    • Avon
      • Bath, Avon, United Kingdom, BA2 3HT
        • Pfizer Investigational Site
    • East Sussex
      • Hastings, East Sussex, United Kingdom, TN34 3EY
        • Pfizer Investigational Site
    • Fife
      • Glenrothes, Fife, United Kingdom, KY6 3LQ
        • Pfizer Investigational Site
      • High Valleyfield, Fife, United Kingdom, KY12 8SJ
        • Pfizer Investigational Site
    • Kent
      • Tunbrige Wells, Kent, United Kingdom, TN1 2EP
        • Pfizer Investigational Site
    • Warwickshire
      • Atherstone, Warwickshire, United Kingdom, CV9 1EU
        • Pfizer Investigational Site
  • United States
    • Florida
      • Clearwater, Florida, United States, 33761
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83703
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83706
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83709
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83651
        • Pfizer Investigational Site
      • Meridian, Idaho, United States, 83642
        • Pfizer Investigational Site
      • Nampa, Idaho, United States, 83651
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Pfizer Investigational Site
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Pfizer Investigational Site
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Pfizer Investigational Site
      • Harleysville, Pennsylvania, United States, 19438
        • Pfizer Investigational Site
    • Utah
      • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bacteriologic response in the Bacteriologic per Protocol population
Time Frame: Test of Cure (TOC) visit (Days 24-28)
Test of Cure (TOC) visit (Days 24-28)

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: Continuous
Continuous
summary of baseline susceptibilities
Time Frame: Study endpoint
Study endpoint
sponsor assessment of clinical response in the Bacteriologic per Protocol population
Time Frame: TOC visit
TOC visit
bacteriologic response for the remaining study populations
Time Frame: TOC visit
TOC visit
sponsor assessment of clinical response for the Bacteriologic per Protocol population
Time Frame: Long-Term Follow-Up (LTFU) visit (Days 38-45)
Long-Term Follow-Up (LTFU) visit (Days 38-45)
bacteriologic response for the Bacteriologic per Protocol population
Time Frame: TOC visit
TOC visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 3, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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