drugset / Trial / NCT00643409

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

NCT00643409

Phase 3 Completed 541 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.

Timeline

Start
2003-01
Primary completion
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule 2 g Oral
Subject Levofloxacin Small molecule 500 mg Oral

Indications