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

Information source: ActivBiotics Pharma, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chlamydia Trachomatis Infection

Intervention: Rifalazil 25 milligram (Drug); Azithromycin 1 gram (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: ActivBiotics Pharma, LLC

Official(s) and/or principal investigator(s):
Chalom B Sayada, MD, PhD, Study Director, Affiliation: ActivBiotics Pharma

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.

Clinical Details

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

Primary outcome: Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22

Secondary outcome:

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

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

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

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Research Site, Birmingham, Alabama 35294, United States

Research Site, San Diego, California 92108, United States

Research Site, Indianapolis, Indiana 46202, United States

Research Site, Las Vegas, Nevada 89106, United States

Research Site, Virginia Beach, Virginia 23456, United States

Additional Information

Starting date: July 2012
Last updated: April 25, 2013

Page last updated: August 23, 2015

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