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

Pfizer598 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

598

Conditions

Pharyngitis Tonsillitis

Interventions

azithromycin (Zithromax)DRUG

azithromycin 500 mg tablet by mouth once daily for 3 days

placeboDRUG

placebo

azithromycin SRDRUG

azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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.

Locations (59)

Outcomes

Primary Outcomes

bacteriologic response in the Bacteriologic per Protocol population

Time frame: Test of Cure (TOC) visit (Days 24-28)

Secondary Outcomes

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Clearwater, Florida, United States

Pfizer Investigational Site

Boise, Idaho, United States

Pfizer Investigational Site

Boise, Idaho, United States

Pfizer Investigational Site

Boise, Idaho, United States

Pfizer Investigational Site

Boise, Idaho, United States

Pfizer Investigational Site

Boise, Idaho, United States

Pfizer Investigational Site

Meridian, Idaho, United States

Pfizer Investigational Site

Nampa, Idaho, United States

Pfizer Investigational Site

Omaha, Nebraska, United States

Pfizer Investigational Site

Hickory, North Carolina, United States

...and 49 more locations