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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Chlamydia Trachomatis Infection

Intervention / Treatment
-----------------
* Drug: Rifalazil 25 milligram
* Drug: Azithromycin 1 gram


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifalazil 25 milligram<br> | Drug: Rifalazil 25 milligram<br>* Single dose of 25 milligram rifalazil to be administered on Day 1.<br>* Other names: KRM-1648;|
| Active Comparator: Azithromycin 1 gram<br>Single dose of Azithromycin 1 gram to be administered on Day 1. | Drug: Azithromycin 1 gram<br>* Single dose of Azithromycin 1 gram to be administered on Day 1.<br>* Other names: Zithromax;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of subjects experiencing adverse events in the two treatment groups. |  | Day 36 (end of study) | 
| Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups. |  | Day 36 (end of study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chlamydia