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NCT Number: NCT01631201

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

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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Key information

Conditions

Chlamydia Trachomatis Infection Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gram-Negative Bacterial Infections Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifalazil 25 milligram

Drug

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

Other names: KRM-1648

Azithromycin 1 gram

Drug

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

Other names: Zithromax

Primary outcomes

  1. Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22

    Time frame: Day 22

    Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.

Secondary outcomes

  1. Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.

    Time frame: Day 36

    Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.

  2. Number of subjects experiencing adverse events in the two treatment groups.

    Time frame: Day 36 (end of study)

  3. Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.

    Time frame: Day 36 (end of study)

Sponsors and collaborators

Lead sponsor

ActivBiotics Pharma, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2012
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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