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”

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 Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: amoxicillin
  • 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• 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)
    Safety Issue?: No

Secondary Measures

• Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit
  • Time Frame: LTFU Visit (Day 38-45)
    Safety Issue?: No
• Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population
  • Time Frame: TOC Visit (Day 24-28)
    Safety Issue?: No
• Clinical response (cure or relapse) at the LTFU visit
  • Time Frame: LTFU Visit (Day 38-45)
    Safety Issue?: No
• Pathogen susceptibility versus bacteriologic response
  • Time Frame: Not reported
    Safety Issue?: No
• Adverse events (AEs) were assessed for all treated subjects
  • Time Frame: Continuous
    Safety Issue?: Yes
• Vital signs and physical examinations were recorded
  • Time Frame: Baseline and as necessary
    Safety Issue?: Yes
• Clinical laboratory testing (hematology and blood chemistry)
  • Time Frame: As necessary
    Safety Issue?: Yes
• Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose
  • Time Frame: Day 1
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643149

Study ID Number: A0661071

ClinicalTrials.gov Identifier: NCT00643149

Health Authority: United States: Food and Drug Administration

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