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Completed

NCT Number: NCT00643149

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

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Key information

Conditions

Tonsillitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin

Drug

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

Azithromycin SR

Drug

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

Primary outcomes

  1. 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

  1. Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit

    Time frame: LTFU Visit (Day 38-45)

  2. Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population

    Time frame: TOC Visit (Day 24-28)

  3. Clinical response (cure or relapse) at the LTFU visit

    Time frame: LTFU Visit (Day 38-45)

  4. Pathogen susceptibility versus bacteriologic response

    Time frame: Not reported

  5. Adverse events (AEs) were assessed for all treated subjects

    Time frame: Continuous

  6. Vital signs and physical examinations were recorded

    Time frame: Baseline and as necessary

  7. Clinical laboratory testing (hematology and blood chemistry)

    Time frame: As necessary

  8. Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 26, 2008
Registry last updated
May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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