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

Primary Purpose

Chlamydia Trachomatis Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rifalazil 25 milligram
Azithromycin 1 gram
Sponsored by
ActivBiotics Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chlamydia Trachomatis Infection focused on measuring Chlamydia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rifalazil 25 milligram

Azithromycin 1 gram

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2012
Last Updated
April 25, 2013
Sponsor
ActivBiotics Pharma, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01631201
Brief Title
Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ActivBiotics Pharma, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chlamydia Trachomatis Infection
Keywords
Chlamydia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifalazil 25 milligram
Arm Type
Experimental
Arm Title
Azithromycin 1 gram
Arm Type
Active Comparator
Arm Description
Single dose of Azithromycin 1 gram to be administered on Day 1.
Intervention Type
Drug
Intervention Name(s)
Rifalazil 25 milligram
Other Intervention Name(s)
KRM-1648
Intervention Description
Single dose of 25 milligram rifalazil to be administered on Day 1.
Intervention Type
Drug
Intervention Name(s)
Azithromycin 1 gram
Other Intervention Name(s)
Zithromax
Intervention Description
Single dose of Azithromycin 1 gram to be administered on Day 1.
Primary Outcome Measure Information:
Title
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22
Description
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
Time Frame
Day 22
Secondary Outcome Measure Information:
Title
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.
Description
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
Time Frame
Day 36
Title
Number of subjects experiencing adverse events in the two treatment groups.
Time Frame
Day 36 (end of study)
Title
Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.
Time Frame
Day 36 (end of study)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chalom B Sayada, MD, PhD
Organizational Affiliation
ActivBiotics Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24798277
Citation
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.
Results Reference
derived

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

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