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

Pfizer1 site in 1 country693 target enrollmentMay 2003

ConditionsTonsillitis

Interventionsamoxicillin azithromycin SR

Drugsamoxicillin azithromycin SR

Overview

Phase: Phase 3
Intervention: amoxicillin
Conditions: Tonsillitis
Sponsor: Pfizer
Enrollment: 693
Locations: 1
Primary Endpoint: Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

March 2004

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility 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.

Arms & Interventions

1

Intervention: amoxicillin

2

Intervention: azithromycin SR

Outcomes

Primary Outcomes

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 Outcomes

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