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

NCT01631201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2013-04-29

No results posted yet for this 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.

Conditions

  • Chlamydia Trachomatis Infection

Interventions

DRUG

Rifalazil 25 milligram

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

DRUG

Azithromycin 1 gram

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

Sponsors & Collaborators

  • ActivBiotics Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Chalom B Sayada, MD, PhD · ActivBiotics Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01631201 on ClinicalTrials.gov