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

Completed · Phase 3

Conditions studied: Tonsillitis

In brief

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.

Key facts

Study ID: NCT00643149
Run by: Pfizer
People needed: 693
Starts: 2003-05-01
Expected to finish: 2004-03-01
Last updated by the study team: 2011-05-17

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.

Where it is running

Pfizer Investigational Site — Hoover, Alabama, United States
Pfizer Investigational Site — Pelham, Alabama, United States
Pfizer Investigational Site — Fresno, California, United States
Pfizer Investigational Site — Fresno, California, United States
Pfizer Investigational Site — San Diego, California, United States
Pfizer Investigational Site — Evansville, Indiana, United States
Pfizer Investigational Site — Evansville, Indiana, United States
Pfizer Investigational Site — Evansville, Indiana, United States
Pfizer Investigational Site — Newburgh, Indiana, United States
Pfizer Investigational Site — Newburgh, Indiana, United States
Pfizer Investigational Site — Wichita, Kansas, United States
Pfizer Investigational Site — Wichita, Kansas, United States
Pfizer Investigational Site — Bardstown, Kentucky, United States
Pfizer Investigational Site — Springfield, Kentucky, United States
Pfizer Investigational Site — Kalamazoo, Michigan, United States
Pfizer Investigational Site — Endwell, New York, United States
Pfizer Investigational Site — Raleigh, North Carolina, United States
Pfizer Investigational Site — Beachwood, Ohio, United States
Pfizer Investigational Site — Chesterland, Ohio, United States
Pfizer Investigational Site — Cleveland, Ohio, United States
Pfizer Investigational Site — Cleveland, Ohio, United States
Pfizer Investigational Site — Willoughby, Ohio, United States
Pfizer Investigational Site — Youngstown, Ohio, United States
Pfizer Investigational Site — McMurray, Pennsylvania, United States
Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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