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CompletedNCT01631201Updated Apr 29, 2013

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

A Phase 2 interventional study of Rifalazil 25 milligram and Azithromycin 1 gram in Chlamydia Trachomatis Infection, sponsored by ActivBiotics Pharma, LLC. Completed at 5 sites in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-04-29.

Sponsored by ActivBiotics Pharma, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
19 Years and older
Sex
Female
01

Study 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.

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Conditions studied

  • Chlamydia Trachomatis Infection

Keywords

  • Chlamydia
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 82 is below the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with ActivBiotics Pharma, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Rifalazil 25 milligram

    Drug: Rifalazil 25 milligram

  • Active comparator
    Azithromycin 1 gram

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

    Drug: Azithromycin 1 gram

Interventions

  • DrugRifalazil 25 milligram

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

    Also known as: KRM-1648

  • DrugAzithromycin 1 gram

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

    Also known as: Zithromax

06

What researchers measure

Primary outcomes

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

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

    Time frame: Day 22

Secondary outcomes

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

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

    Time frame: Day 36

  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)

07

Study locations

5 sites
  • Research Site
    Birmingham, Alabama 35294, United States
  • Research Site
    San Diego, California 92108, United States
  • Research Site
    Indianapolis, Indiana 46202, United States
  • Research Site
    Las Vegas, Nevada 89106, United States
  • Research Site
    Virginia Beach, Virginia 23456, United States
08

References and documents

Publications

  • 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. PubMed 24798277 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01631201
Lead sponsor
ActivBiotics Pharma, LLC
Responsible party
Sponsor
First posted
Jun 29, 2012
Start date
Jul 2012
Primary completion
Mar 2013
Completion
Apr 2013
Last update
Apr 29, 2013

Study contacts

Chalom B Sayada, MD, PhD
study director · ActivBiotics Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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