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

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NCT00643149

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hoover, Alabama, 35244 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Patients were excluded if they had previously diagnosed disease(s) of immune function or
treatment with any systemic antibiotic within the previous 7 days.

NCT00643149
Pfizer
Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

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A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A ?-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Tonsillitis
  • Drug: amoxicillin
    10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
  • 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
  • Experimental: 1
    Intervention: Drug: amoxicillin
  • Experimental: 2
    Intervention: Drug: azithromycin SR
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
693
March 2004
Not Provided

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.
Sexes Eligible for Study: All
2 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Costa Rica,   Guatemala,   India,   United States
 
 
NCT00643149
A0661071
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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