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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643149

Purpose

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat Streptococcal Infections Tonsils and Adenoids

Drug Information available for: Amoxicillin sodium Amoxicillin Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population [ Time Frame: TOC visit (Day 24-28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit [ Time Frame: LTFU Visit (Day 38-45) ] [ Designated as safety issue: No ]
Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population [ Time Frame: TOC Visit (Day 24-28) ] [ Designated as safety issue: No ]
Clinical response (cure or relapse) at the LTFU visit [ Time Frame: LTFU Visit (Day 38-45) ] [ Designated as safety issue: No ]
Pathogen susceptibility versus bacteriologic response [ Time Frame: Not reported ] [ Designated as safety issue: No ]
Adverse events (AEs) were assessed for all treated subjects [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
Vital signs and physical examinations were recorded [ Time Frame: Baseline and as necessary ] [ Designated as safety issue: Yes ]
Clinical laboratory testing (hematology and blood chemistry) [ Time Frame: As necessary ] [ Designated as safety issue: Yes ]
Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]

Enrollment:	693
Study Start Date:	May 2003
Study Completion Date:	March 2004

Arms	Assigned Interventions
Experimental: 1	Drug: amoxicillin 10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
Experimental: 2	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

Eligibility

Ages Eligible for Study:	2 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643149

Show 45 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00643149 History of Changes
Other Study ID Numbers:	A0661071
Study First Received:	March 19, 2008
Last Updated:	May 16, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

Amoxicillin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012