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

April 25, 2013 updated by: ActivBiotics Pharma, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rifalazil 25 milligram
Drug: Rifalazil 25 milligram
Single dose of 25 milligram rifalazil to be administered on Day 1.
Other Names:
  • KRM-1648
ACTIVE_COMPARATOR: Azithromycin 1 gram
Single dose of Azithromycin 1 gram to be administered on Day 1.
Drug: Azithromycin 1 gram
Single dose of Azithromycin 1 gram to be administered on Day 1.
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 36
Number of subjects experiencing adverse events in the two treatment groups.
Time Frame: Day 36 (end of study)
Day 36 (end of study)
Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.
Time Frame: Day 36 (end of study)
Day 36 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ActivBiotics Pharma, LLC

Investigators

  • Study Director: Chalom B Sayada, MD, PhD, ActivBiotics Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (ESTIMATE)

June 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APL-1648-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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