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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631201
• Other study ID #: APL-1648-027
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2012
• Last updated: April 25, 2013
• Start date: July 2012
• Est. completion date: April 2013

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chlamydia Infections
• Chlamydia Trachomatis Infection
• Infection

Intervention

Drug:
• Rifalazil 25 milligram
Single dose of 25 milligram rifalazil to be administered on Day 1.
• Azithromycin 1 gram
Single dose of Azithromycin 1 gram to be administered on Day 1.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ActivBiotics Pharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

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