A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
- Registration Number
- NCT00643149
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 693
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.
Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 amoxicillin - 2 azithromycin SR -
- Primary Outcome Measures
Name Time Method Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population TOC visit (Day 24-28)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇮🇳Mumbai, Maharashtra, India