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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01631201

Enrollment

Registered

2012-06-29

Start date

2012-07-31

Completion date

2013-04-30

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Trachomatis Infection

Keywords

Chlamydia

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.

Interventions

DRUGRifalazil 25 milligram

Single dose of 25 milligram rifalazil to be administered on Day 1.

DRUGAzithromycin 1 gram

Single dose of Azithromycin 1 gram to be administered on Day 1.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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)	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026