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

Phase 3

Completed

• Conditions: Pharyngitis; Tonsillitis
• Interventions: Drug: azithromycin SR; Drug: azithromycin (Zithromax); Drug: placebo

• Registration Number: NCT00644293
• Lead Sponsor: Pfizer

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

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-04
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-26
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 598

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	azithromycin SR	-
2	placebo	-
1	azithromycin (Zithromax)	-

Primary Outcome Measures

Name	Time	Method
bacteriologic response in the Bacteriologic per Protocol population	Test of Cure (TOC) visit (Days 24-28)

Secondary Outcome Measures

Name	Time	Method
summary of baseline susceptibilities	Study endpoint
sponsor assessment of clinical response in the Bacteriologic per Protocol population	TOC visit
bacteriologic response for the remaining study populations	TOC visit
sponsor assessment of clinical response for the Bacteriologic per Protocol population	Long-Term Follow-Up (LTFU) visit (Days 38-45)
bacteriologic response for the Bacteriologic per Protocol population	TOC visit
adverse events	Continuous

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Kent, United Kingdom