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

Condition(s) targeted: Tonsillitis

Intervention: amoxicillin (Drug); azithromycin SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: 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

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

Primary outcome: Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population

Secondary outcome:

Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit

Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population

Clinical response (cure or relapse) at the LTFU visit

Pathogen susceptibility versus bacteriologic response

Adverse events (AEs) were assessed for all treated subjects

Vital signs and physical examinations were recorded

Clinical laboratory testing (hematology and blood chemistry)

Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Guatemala, Guatemala

Pfizer Investigational Site, Hoover, Alabama 35244, United States

Pfizer Investigational Site, Pelham, Alabama 35124, United States

Pfizer Investigational Site, Calgary, Alberta T2T 5C7, Canada

Pfizer Investigational Site, Hyderabad, Andhara Pradesh 500 033, India

Pfizer Investigational Site, COQUITLAM, British Columbia V3K 3P4, Canada

Pfizer Investigational Site, San Diego, California 92128, United States

Pfizer Investigational Site, Fresno, California 93710, United States

Pfizer Investigational Site, Fresno, California 93720, United States

Pfizer Investigational Site, EVANSVILLE, Indiana 47713, United States

Pfizer Investigational Site, Evansville, Indiana 47710, United States

Pfizer Investigational Site, Evansville, Indiana 47714, United States

Pfizer Investigational Site, Newburgh, Indiana 47360, United States

Pfizer Investigational Site, Newburgh, Indiana 47630, United States

Pfizer Investigational Site, Wichita, Kansas 67207, United States

Pfizer Investigational Site, Wichita, Kansas 67212, United States

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India

Pfizer Investigational Site, Bardstown, Kentucky 40004, United States

Pfizer Investigational Site, Springfield, Kentucky 40069, United States

Pfizer Investigational Site, Kochi, Kerala 682 026, India

Pfizer Investigational Site, Mumbai, Maharashtra 400 0124, India

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1M3, Canada

Pfizer Investigational Site, Kalamazoo, Michigan 49009, United States

Pfizer Investigational Site, Endwell, New York 13760, United States

Pfizer Investigational Site, Raleigh, North Carolina 27609, United States

Pfizer Investigational Site, Beachwood, Ohio 44122, United States

Pfizer Investigational Site, Chesterland, Ohio 44026, United States

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, Cleveland, Ohio 44111, United States

Pfizer Investigational Site, Willoughby, Ohio 44094, United States

Pfizer Investigational Site, Youngstown, Ohio 44501, United States

Pfizer Investigational Site, McMurray, Pennsylvania 15317, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15234, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15241, United States

Pfizer Investigational Site, Escazu, San Jose, Costa Rica

Pfizer Investigational Site, La Uruca, San Jose, Costa Rica

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 7H9, Canada

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States

Pfizer Investigational Site, Bryan, Texas 77802, United States

Pfizer Investigational Site, West Jordan, Utah 84088, United States

Pfizer Investigational Site, Salt Lake City, Utah 84121, United States

Pfizer Investigational Site, Salt Lake City, Utah 84109, United States

Pfizer Investigational Site, Salt Lake City, Utah 84103, United States

Pfizer Investigational Site, Salt Lake City, Utah 84111, United States

To obtain contact information for a study center near you, click here.

Starting date: May 2003
Ending date: March 2004
Last updated: March 19, 2008