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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amoxicillin | Drug | 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours |
| |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hoover | Alabama | 35244 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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 |
|
| 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 |
| Pelham |
| Alabama |
| 35124 |
| United States |
| Pfizer Investigational Site | Fresno | California | 93710 | United States |
| Pfizer Investigational Site | Fresno | California | 93720 | United States |
| Pfizer Investigational Site | San Diego | California | 92128 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47710 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47713 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47714 | United States |
| Pfizer Investigational Site | Newburgh | Indiana | 47360 | United States |
| Pfizer Investigational Site | Newburgh | Indiana | 47630 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67212 | United States |
| Pfizer Investigational Site | Bardstown | Kentucky | 40004 | United States |
| Pfizer Investigational Site | Springfield | Kentucky | 40069 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49009 | United States |
| Pfizer Investigational Site | Endwell | New York | 13760 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Pfizer Investigational Site | Beachwood | Ohio | 44122 | United States |
| Pfizer Investigational Site | Chesterland | Ohio | 44026 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44111 | United States |
| Pfizer Investigational Site | Willoughby | Ohio | 44094 | United States |
| Pfizer Investigational Site | Youngstown | Ohio | 44501 | United States |
| Pfizer Investigational Site | McMurray | Pennsylvania | 15317 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15234 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Pfizer Investigational Site | Bryan | Texas | 77802 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84103 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84109 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84111 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84121 | United States |
| Pfizer Investigational Site | West Jordan | Utah | 84088 | United States |
| Pfizer Investigational Site | Calgary | Alberta | T2T 5C7 | Canada |
| Pfizer Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 7H9 | Canada |
| Pfizer Investigational Site | Escazú | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | San José | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Uruca | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | San José | Costa Rica |
| Pfizer Investigational Site | Guatemala City | Departamento de Guatemala | Guatemala |
| Pfizer Investigational Site | Hyderabad | Andhara Pradesh | 500 033 | India |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682 026 | India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400 0124 | India |
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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