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

Completed · Phase 2

Conditions studied: Chlamydia Trachomatis Infection

In brief

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.

Key facts

Study ID

NCT01631201

Run by

ActivBiotics Pharma, LLC

People needed

82

Starts

2012-07-01

Expected to finish

2013-04-01

Last updated by the study team

2013-04-29

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female ≥ 19 years old diagnosed with genital chlamydia trachomatis infection.
• Use an effective method of contraception.
• Agree to be abstinent or to have partners use condoms for all sexual activities during the study.

You may not qualify if…

• Subject or sexual partner is known to have gonorrhea.
• History of repeated chlamydia trachomatis infection.
• HIV, syphilis, or active Hepatitis B or C infection.
• Treatment with antimicrobial therapy with known activity against chlamydia trachomatis within 4 weeks of enrollment.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — San Diego, California, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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