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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643149
First received: March 19, 2008
Last updated: May 16, 2011
Last verified: May 2011
  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:


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:
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 April 16, 2014