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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644293
First Posted: March 26, 2008
Last Update Posted: June 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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) ]

Secondary Outcome Measures:
  • sponsor assessment of clinical response in the Bacteriologic per Protocol population [ Time Frame: TOC visit ]
  • bacteriologic response for the remaining study populations [ Time Frame: TOC visit ]
  • sponsor assessment of clinical response for the Bacteriologic per Protocol population [ Time Frame: Long-Term Follow-Up (LTFU) visit (Days 38-45) ]
  • bacteriologic response for the Bacteriologic per Protocol population [ Time Frame: TOC visit ]
  • summary of baseline susceptibilities [ Time Frame: Study endpoint ]
  • adverse events [ Time Frame: Continuous ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644293


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

Additional Information:
Responsible Party: Director, Clinical Trial Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00644293     History of Changes
Other Study ID Numbers: A0661119
First Submitted: March 19, 2008
First Posted: March 26, 2008
Last Update Posted: June 8, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Pharyngitis
Tonsillitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents


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