Official Title: “A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• bacteriologic response in the Bacteriologic per Protocol population
  • Time Frame: Test of Cure (TOC) visit (Days 24-28)
    Safety Issue?: No

Secondary Measures

• sponsor assessment of clinical response in the Bacteriologic per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• bacteriologic response for the remaining study populations
  • Time Frame: TOC visit
    Safety Issue?: No
• sponsor assessment of clinical response for the Bacteriologic per Protocol population
  • Time Frame: Long-Term Follow-Up (LTFU) visit (Days 38-45)
    Safety Issue?: No
• bacteriologic response for the Bacteriologic per Protocol population
  • Time Frame: TOC visit
    Safety Issue?: No
• summary of baseline susceptibilities
  • Time Frame: Study endpoint
    Safety Issue?: No
• adverse events
  • Time Frame: Continuous
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00644293

Study ID Number: A0661119

ClinicalTrials.gov Identifier: NCT00644293

Health Authority: United States: Food and Drug Administration

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