Chlamydia Trachomatis Infection Clinical Trial
Official title:
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
Verified date | April 2013 |
Source | ActivBiotics Pharma, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | April 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Indianapolis | Indiana |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | San Diego | California |
United States | Research Site | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
ActivBiotics Pharma, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22 | Microbiologic test result will be reported as positive or negative for chlamydia trachomatis. | Day 22 | No |
Secondary | Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36. | Microbiologic test result will be reported as positive or negative for chlamydia trachomatis. | Day 36 | No |
Secondary | Number of subjects experiencing adverse events in the two treatment groups. | Day 36 (end of study) | Yes | |
Secondary | Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups. | Day 36 (end of study) | Yes |
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