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 - Tabular View

Tracking Information

First Received Date ^ICMJE

March 19, 2008

Last Updated Date

March 26, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00644293 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Pharyngitis
Tonsillitis

Intervention ^ICMJE

Drug: azithromycin (Zithromax)
Drug: placebo
Drug: azithromycin SR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

598

Completion Date

April 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

13 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Finland, France, Germany, India, Italy, Netherlands, Norway, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00644293

Responsible Party

Director, Clinical Trial Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0661119

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP