Tonsillitis
Conditions
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.
Interventions
DRUGamoxicillin
10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
DRUGazithromycin SR
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
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population | TOC visit (Day 24-28) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit | LTFU Visit (Day 38-45) |
| 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 |
| Adverse events (AEs) were assessed for all treated subjects | Continuous |
Countries
Canada, Costa Rica, Guatemala, India, United States
Outcome results
None listed