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

Pfizer693 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

693

Conditions

Tonsillitis

Interventions

amoxicillinDRUG

10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours

azithromycin SRDRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (46)

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

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Hoover, Alabama, United States

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Pelham, Alabama, United States

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Fresno, California, United States

Pfizer Investigational Site

Fresno, California, United States

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San Diego, California, United States

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Evansville, Indiana, United States

Pfizer Investigational Site

Evansville, Indiana, United States

Pfizer Investigational Site

Evansville, Indiana, United States

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Newburgh, Indiana, United States

Pfizer Investigational Site

Newburgh, Indiana, United States

...and 36 more locations