A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

May 16, 2011 updated by: Pfizer

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A Β-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children

The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

693

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Pfizer Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 7H9
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Escazu, San Jose, Costa Rica
        • Pfizer Investigational Site
      • La Uruca, San Jose, Costa Rica
        • Pfizer Investigational Site
  • Guatemala
      • Guatemala, Guatemala
        • Pfizer Investigational Site
  • India
    • Andhara Pradesh
      • Hyderabad, Andhara Pradesh, India, 500 033
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 0124
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Hoover, Alabama, United States, 35244
        • Pfizer Investigational Site
      • Pelham, Alabama, United States, 35124
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47714
        • Pfizer Investigational Site
      • Evansville, Indiana, United States, 47713
        • Pfizer Investigational Site
      • Newburgh, Indiana, United States, 47360
        • Pfizer Investigational Site
      • Newburgh, Indiana, United States, 47630
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67212
        • Pfizer Investigational Site
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Pfizer Investigational Site
      • Springfield, Kentucky, United States, 40069
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
    • New York
      • Endwell, New York, United States, 13760
        • Pfizer Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Chesterland, Ohio, United States, 44026
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44111
        • Pfizer Investigational Site
      • Willoughby, Ohio, United States, 44094
        • Pfizer Investigational Site
      • Youngstown, Ohio, United States, 44501
        • Pfizer Investigational Site
    • Pennsylvania
      • McMurray, Pennsylvania, United States, 15317
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15234
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15241
        • Pfizer Investigational Site
    • Texas
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84103
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84111
        • 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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.

Exclusion Criteria:

Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.

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: amoxicillin
10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
Experimental: 2
Drug: azithromycin SR
60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
Time Frame: TOC visit (Day 24-28)
TOC visit (Day 24-28)

Secondary Outcome Measures

Outcome Measure
Time Frame
Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit
Time Frame: LTFU Visit (Day 38-45)
LTFU Visit (Day 38-45)
Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population
Time Frame: TOC Visit (Day 24-28)
TOC Visit (Day 24-28)
Clinical response (cure or relapse) at the LTFU visit
Time Frame: LTFU Visit (Day 38-45)
LTFU Visit (Day 38-45)
Pathogen susceptibility versus bacteriologic response
Time Frame: Not reported
Not reported
Adverse events (AEs) were assessed for all treated subjects
Time Frame: Continuous
Continuous
Vital signs and physical examinations were recorded
Time Frame: Baseline and as necessary
Baseline and as necessary
Clinical laboratory testing (hematology and blood chemistry)
Time Frame: As necessary
As necessary
Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose
Time Frame: Day 1
Day 1

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

May 1, 2003

Study Completion (Actual)

March 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)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661071

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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