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NCT00643149 Clinical Trial

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

Tonsillitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643149
Other study ID # A0661071
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated May 16, 2011
Start date May 2003
Est. completion date March 2004

Study information
Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 693
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 12 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• amoxicillin
10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
• 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

Locations
Country Name City State
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Coquitlam British Columbia
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Winnipeg Manitoba
Costa Rica Pfizer Investigational Site Escazu San Jose
Costa Rica Pfizer Investigational Site La Uruca San Jose
Costa Rica Pfizer Investigational Site San Jose
Guatemala Pfizer Investigational Site Guatemala
India Pfizer Investigational Site Bangalore Karnataka
India Pfizer Investigational Site Hyderabad Andhara Pradesh
India Pfizer Investigational Site Kochi Kerala
India Pfizer Investigational Site Mumbai Maharashtra
United States Pfizer Investigational Site Bardstown Kentucky
United States Pfizer Investigational Site Beachwood Ohio
United States Pfizer Investigational Site Bryan Texas
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 Endwell New York
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 Fresno California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Hoover Alabama
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Lake Jackson Texas
United States Pfizer Investigational Site McMurray Pennsylvania
United States Pfizer Investigational Site Newburgh Indiana
United States Pfizer Investigational Site Newburgh Indiana
United States Pfizer Investigational Site Pelham Alabama
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Springfield Kentucky
United States Pfizer Investigational Site West Jordan Utah
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Willoughby Ohio
United States Pfizer Investigational Site Youngstown Ohio

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Costa Rica,  Guatemala,  India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population TOC visit (Day 24-28) No
Secondary Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit LTFU Visit (Day 38-45) No
Secondary Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population TOC Visit (Day 24-28) No
Secondary Clinical response (cure or relapse) at the LTFU visit LTFU Visit (Day 38-45) No
Secondary Pathogen susceptibility versus bacteriologic response Not reported No
Secondary Adverse events (AEs) were assessed for all treated subjects Continuous Yes
Secondary Vital signs and physical examinations were recorded Baseline and as necessary Yes
Secondary Clinical laboratory testing (hematology and blood chemistry) As necessary Yes
Secondary Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose Day 1 Yes
See also
  Status Clinical Trial Phase
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Completed NCT04551196 - Management of Post-Tonsillectomy Pain in Pediatric Patients Phase 3
Active, not recruiting NCT03654742 - Intracapsular Tonsillectomy in Adults N/A
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02712307 - Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci Phase 4
Enrolling by invitation NCT02205580 - Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children Phase 4
Completed NCT01721486 - Acetaminophen's Efficacy For Post-operative Pain Phase 4
Active, not recruiting NCT01691690 - Analgesic Effect of IV Acetaminophen in Tonsillectomies Phase 2
Completed NCT00393744 - Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Active, not recruiting NCT00136877 - Tonsillectomy in Recurrent Tonsillitis N/A
Recruiting NCT04646525 - The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Recruiting NCT03137823 - Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface N/A
Completed NCT02571075 - Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea N/A
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3
Completed NCT01465009 - Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold Phase 4
Recruiting NCT04164511 - Does Ice Cream Help With Post-tonsillectomy Pain
Completed NCT04653376 - Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases

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