Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 3/30/2013 |
| Start Date: | July 2012 |
| End Date: | January 2013 |
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
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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5
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