Clinical trial NCT01631201: Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chlamydia Trachomatis Infection
Keywords: Chlamydia
Lead sponsor: ActivBiotics Pharma, LLC
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 82
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22
timeFrame: Day 22
Secondary outcomes:
measure: Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.
timeFrame: Day 36
measure: Number of subjects experiencing adverse events in the two treatment groups.
timeFrame: Day 36 (end of study)
measure: Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.
timeFrame: Day 36 (end of study)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: San Diego
country: United States
facility: Research Site
state: California
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: ActivBiotics Pharma
name: Chalom B Sayada, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Geisler WM, Pascual ML, Mathew J, Koltun WD, Morgan F, Batteiger BE, Mayes A, Tao S, Hurwitz SJ, Sayada C, Schinazi RF. Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women. Antimicrob Agents Chemother. 2014 Jul;58(7):4014-9. doi: 10.1128/AAC.02521-14. Epub 2014 May 5.