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

ActivBiotics Pharma

Status and phase: Completed; Phase 2

Conditions: Chlamydia Trachomatis Infection

Treatments: Drug: Azithromycin 1 gram; Drug: Rifalazil 25 milligram

Study type: Interventional

Funder types: Industry

Identifiers

NCT01631201

APL-1648-027

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: Female

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups

Rifalazil 25 milligram

Experimental group

Treatment:

Drug: Rifalazil 25 milligram

Azithromycin 1 gram

Active Comparator group

Description:

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

Treatment:

Drug: Azithromycin 1 gram