NCT01631201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

June 18, 2012

Last Update Submit

April 25, 2013

Conditions

Chlamydia Trachomatis Infection

Keywords

Chlamydia

Outcome Measures

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.

    Day 22

Secondary Outcomes (3)

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

    Day 36

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

    Day 36 (end of study)

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

    Day 36 (end of study)

Study Arms (2)

Rifalazil 25 milligram

EXPERIMENTAL
Drug: Rifalazil 25 milligram

Azithromycin 1 gram

ACTIVE COMPARATOR

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

Drug: Azithromycin 1 gram

Interventions

Rifalazil 25 milligramDRUG

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

Also known as: KRM-1648
Rifalazil 25 milligram
Azithromycin 1 gramDRUG

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

Also known as: Zithromax
Azithromycin 1 gram

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Birmingham, Alabama, 35294, United States

Location

Research Site

San Diego, California, 92108, United States

Location

Research Site

Indianapolis, Indiana, 46202, United States

Location

Research Site

Las Vegas, Nevada, 89106, United States

Location

Research Site

Virginia Beach, Virginia, 23456, United States

Location

Related Publications (1)

  • 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.

    PMID: 24798277DERIVED

MeSH Terms

Conditions

Chlamydia Infections

Interventions

KRM 1648Azithromycin

Condition Hierarchy (Ancestors)

Chlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Chalom B Sayada, MD, PhD

    ActivBiotics Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 29, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

April 29, 2013

Record last verified: 2013-04

Locations

US(5)