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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014