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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Tonsillitis; Pharyngitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644293

A0661119

Details and patient eligibility

About

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.

Enrollment: 598 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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598 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: azithromycin (Zithromax)

Drug: placebo

Drug: placebo

2

Experimental group

Treatment:

Drug: azithromycin SR

Drug: placebo

Drug: placebo