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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Clearwater, Florida, 33761 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharyngitis, Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS)
pharyngitis/tonsillitis and a positive rapid antigen detection test or 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 treatment with any systemic antibiotic within the
previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known
carriers of GABHS.

NCT00644293
Pfizer
Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A ?-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults
To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Pharyngitis
  • Tonsillitis
  • Drug: azithromycin (Zithromax)
    azithromycin 500 mg tablet by mouth once daily for 3 days
  • Drug: placebo
    placebo
  • Drug: azithromycin SR
    azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
  • Experimental: 1
    Interventions:
    • Drug: azithromycin (Zithromax)
    • Drug: placebo
  • Experimental: 2
    Interventions:
    • Drug: azithromycin SR
    • Drug: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
April 2004
Not Provided

Inclusion Criteria:

  • Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS

Exclusion Criteria:

  • Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   India,   Italy,   Netherlands,   Norway,   United Kingdom,   United States
 
 
NCT00644293
A0661119
No
Not Provided
Not Provided
Director, Clinical Trial Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

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

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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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