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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00643149 |
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.
Condition | Intervention | Phase |
---|---|---|
Tonsillitis |
Drug: amoxicillin Drug: azithromycin SR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official 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 |
Enrollment: | 626 |
Study Start Date: | May 2003 |
Study Completion Date: | March 2004 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: amoxicillin
10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
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2: Experimental |
Drug: azithromycin 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
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Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts 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.
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661071 |
Study First Received: | March 19, 2008 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00643149 |
Health Authority: | United States: Food and Drug Administration |
Amoxicillin Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Streptococcal Infections |
Azithromycin Tonsillitis Stomatognathic Diseases Pharyngitis Pharyngeal Diseases |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |