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Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ancenis, , 44150 France
Contact
1-800-718-1021
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
3-15 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Outpatients with an acute pharyngitis erythematous or erythematopultaceous with
modification of pharynx aspect and fever of ≥38° C, and patients either with or without
spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node
(mandibular area) were eligible for inclusion. All subjects should have had a positive
rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.

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

Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were
excluded.

NCT00643539
Pfizer
Completed
Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

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Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat
Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis
The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Tonsillitis
  • Drug: Zithromax
    azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days
  • Drug: Clamoxyl
    Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days
  • Experimental: 1
    Intervention: Drug: Clamoxyl
  • Experimental: 2
    Intervention: Drug: Zithromax
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
July 2003
Not Provided

Inclusion Criteria:

Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ?38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.

Exclusion Criteria:

Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.

Sexes Eligible for Study: All
3 Years to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00643539
A0661037
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

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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[email protected]



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