Overview

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

Status:
Completed

Trial end date:
2004-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Amoxicillin
Azithromycin

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.