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 - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00644293

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 III

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:

MedlinePlus related topics: Sore Throat Streptococcal Infections Tonsils and Adenoids

Drug Information available for: Azithromycin

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012