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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • 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

  • Experimental: 1
  • Experimental: 2

Clinical Trial Outcome Measures

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)

Secondary Measures

  • Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit
    • Time Frame: 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)
  • Clinical response (cure or relapse) at the LTFU visit
    • Time Frame: LTFU Visit (Day 38-45)
  • Pathogen susceptibility versus bacteriologic response
    • Time Frame: Not reported
  • Adverse events (AEs) were assessed for all treated subjects
    • Time Frame: Continuous
  • Vital signs and physical examinations were recorded
    • Time Frame: Baseline and as necessary
  • Clinical laboratory testing (hematology and blood chemistry)
    • Time Frame: 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

Participating in This Clinical Trial

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: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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