Clinical trial NCT00643149: A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tonsillitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 693
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Bacteriologic response (eradication or persistence) at the Test of Cure (TOC) visit in the Bacteriologic Per Protocol population
timeFrame: TOC visit (Day 24-28)
Secondary outcomes:
measure: Bacteriologic eradication rate at the Long-Term Follow-Up (LTFU) visit
timeFrame: LTFU Visit (Day 38-45)
measure: Clinical response (clinical cure or failure) at the TOC visit in the Bacteriologic Per Protocol population
timeFrame: TOC Visit (Day 24-28)
measure: Clinical response (cure or relapse) at the LTFU visit
timeFrame: LTFU Visit (Day 38-45)
measure: Pathogen susceptibility versus bacteriologic response
timeFrame: Not reported
measure: Adverse events (AEs) were assessed for all treated subjects
timeFrame: Continuous
measure: Vital signs and physical examinations were recorded
timeFrame: Baseline and as necessary
measure: Clinical laboratory testing (hematology and blood chemistry)
timeFrame: As necessary
measure: Azithromycin serum concentrations were determined for patients who vomited within 30 minutes of receiving their azithromycin SR/placebo dose
timeFrame: Day 1
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Pelham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Bardstown
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Chesterland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Willoughby
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: McMurray
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Coquitlam
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Escazu
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: La Uruca
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhara Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: