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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01631201
Other study ID # APL-1648-027
Secondary ID
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


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
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