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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Single dose of 25 milligram rifalazil to be administered on Day 1.
Single dose of Azithromycin 1 gram to be administered on Day 1.
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
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.
Time frame: Day 22
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.
Time frame: Day 36
Number of subjects experiencing adverse events in the two treatment groups.
Time frame: Day 36 (end of study)
Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.
Time frame: Day 36 (end of study)
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Research Site
Virginia Beach, Virginia, United States