NCT01631201

Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women

A Phase 2b, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Safety and Efficacy of Rifalazil (25 Milligram) Compared With Azithromycin (1 Gram) for the Treatment of Uncomplicated Genital Chlamydia Trachomatis Infection in Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: ActivBiotics Pharma, LLC · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.

Conditions

• Chlamydia Trachomatis Infection

Interventions

Type	Name	Description
DRUG	Rifalazil 25 milligram	Single dose of 25 milligram rifalazil to be administered on Day 1.
DRUG	Azithromycin 1 gram	Single dose of Azithromycin 1 gram to be administered on Day 1.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2012-06-29
• Last updated: 2013-04-29

Locations

5 sites across 1 country: United States