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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644293
First received: March 19, 2008
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Pharyngitis
Tonsillitis
Drug: azithromycin (Zithromax)
Drug: placebo
Drug: azithromycin SR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • bacteriologic response in the Bacteriologic per Protocol population [ Time Frame: Test of Cure (TOC) visit (Days 24-28) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sponsor assessment of clinical response in the Bacteriologic per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • bacteriologic response for the remaining study populations [ Time Frame: TOC visit ] [ Designated as 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) ] [ Designated as safety issue: No ]
  • bacteriologic response for the Bacteriologic per Protocol population [ Time Frame: TOC visit ] [ Designated as safety issue: No ]
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Enrollment: 598
Study Start Date: January 2003
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1 Drug: azithromycin (Zithromax)
azithromycin 500 mg tablet by mouth once daily for 3 days
Drug: placebo
placebo
Experimental: 2 Drug: azithromycin SR
azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644293

  Show 59 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644293     History of Changes
Other Study ID Numbers: A0661119
Study First Received: March 19, 2008
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014