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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chlamydia Trachomatis Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rifalazil 25 milligram

Group Type EXPERIMENTAL

Rifalazil 25 milligram

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Azithromycin 1 gram

Intervention Type DRUG

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

Interventions

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Rifalazil 25 milligram

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

Intervention Type DRUG

Azithromycin 1 gram

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

Intervention Type DRUG

Other Intervention Names

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KRM-1648 Zithromax

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No