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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 November 12, 2019
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Study Location
Pfizer Investigational Site
Hoover, Alabama, 35244 United States
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tonsillitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: amoxicillin
  • Experimental: 2
    Intervention: Drug: azithromycin SR
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2011)		693
Original Actual Enrollment  ICMJE
 (submitted: March 19, 2008)		626
Actual Study Completion Date  ICMJE March 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Costa Rica,   Guatemala,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643149
Other Study ID Numbers  ICMJE A0661071
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2011

ICMJE     Data element required by the

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

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