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

Phase 2

Completed

• Conditions: Chlamydia Trachomatis Infection
• Interventions: Drug: Rifalazil 25 milligram; Drug: Azithromycin 1 gram

• Registration Number: NCT01631201
• Lead Sponsor: ActivBiotics Pharma, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Study Start: 2012-07
• Primary Completion: 2013-03
• Status Verified: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rifalazil 25 milligram	Rifalazil 25 milligram	-
Azithromycin 1 gram	Azithromycin 1 gram	Single dose of Azithromycin 1 gram to be administered on Day 1.

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22	Day 22	Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.	Day 36	Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.	Day 36 (end of study)
Number of subjects experiencing adverse events in the two treatment groups.	Day 36 (end of study)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Virginia Beach, Virginia, United States