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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ActivBiotics Pharma, LLC
ClinicalTrials.gov Identifier:
NCT01631201
First received: June 18, 2012
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chlamydia Trachomatis Infection
 Drug: Rifalazil 25 milligram
Drug: Azithromycin 1 gram
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ActivBiotics Pharma, LLC:

Primary Outcome Measures:
  • Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22 [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
    Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.


Secondary Outcome Measures:
  • Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36. [ Time Frame: Day 36 ] [ Designated as safety issue: No ]
    Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.

  • Number of subjects experiencing adverse events in the two treatment groups. [ Time Frame: Day 36 (end of study) ] [ Designated as safety issue: Yes ]
  • Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups. [ Time Frame: Day 36 (end of study) ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifalazil 25 milligram Drug: Rifalazil 25 milligram
Single dose of 25 milligram rifalazil to be administered on Day 1.
Other Name: 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 Name: Zithromax

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631201

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, California
Research Site
San Diego, California, United States, 92108
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89106
United States, Virginia
Research Site
Virginia Beach, Virginia, United States, 23456
Sponsors and Collaborators
ActivBiotics Pharma, LLC
Investigators
Study Director: Chalom B Sayada, MD, PhD ActivBiotics Pharma
  More Information

No publications provided

Responsible Party: ActivBiotics Pharma, LLC
ClinicalTrials.gov Identifier: NCT01631201     History of Changes
Other Study ID Numbers: APL-1648-027
Study First Received: June 18, 2012
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ActivBiotics Pharma, LLC:
Chlamydia

Additional relevant MeSH terms:
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
 Azithromycin
KRM 1648
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on May 16, 2013