TBTC Study 24: Intermittent Treatment of TB With Isoniazid Resistance or Intolerance
- Conditions
- Tuberculosis
- Interventions
- Registration Number
- NCT00023374
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
This study is a prospective, open-label, nonrandomized trial using a largely-intermittent, six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to the presence of initial isoniazid resistance or intolerance. Subjects are enrolled after resistance or intolerance to isoniazid has been documented, and are treated for a total of six months (nine months if baseline chest x-ray shows cavitation and 2-month sputum culture is positive) with twice weekly or thrice weekly rifampin, ethambutol, and pyrazinamide.
- Detailed Description
Primary Objective:
To evaluate the efficacy of a directly-observed, largely-intermittent, six-month regimen of rifampin, pyrazinamide, ethambutol among patients with culture confirmed isoniazid-resistant M. tuberculosis.
Secondary Objectives:
To describe the rate, severity and timing of toxicities and drug intolerances associated with this treatment regimen.
To describe the utility of this regimen among patients who are unable to continue the standard 4-drug regimen due to the development of intolerance to isoniazid
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rifampin+PZA+Ethambutol Pyrazinamide 6 mos of intermittent (2 or 3 times weekly) therapy with REZ Rifampin+PZA+Ethambutol REZ 6 mos of intermittent (2 or 3 times weekly) therapy with REZ Rifampin+PZA+Ethambutol Ethambutol 6 mos of intermittent (2 or 3 times weekly) therapy with REZ Rifampin+PZA+Ethambutol Rifampin 6 mos of intermittent (2 or 3 times weekly) therapy with REZ
- Primary Outcome Measures
Name Time Method Combined endpoint of bacteriologic plus clinical failure and relapse within 2 years of completing treatment among patients with isoniazid-resistant tuberculosis and among patients enrolled with intolerance to isoniazid 30 mos
- Secondary Outcome Measures
Name Time Method Bacteriologic failure or relapse in patients with resistance to streptomycin 30 mos Bacteriologic failure or relapse among patient with history of prior treatment 30 mos Bacteriologic failure or relapse by duration of isoniazid received 30 mos Occurrence and timing of toxicities and drug intolerances 6 mos Occurrence of acquired resistance 30 mos Proportion with documented conversion of 8-week sputum cultures 8 wks Bacteriologic failure or relapse among patients with positive 8-week sputum cultures 30 mos Time to completion and the frequency of successful completion 6 mos
Trial Locations
- Locations (23)
New York University School of Medicine
🇺🇸New York, New York, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Washington, D.C. VAMC
🇺🇸Washington, District of Columbia, United States
Hines VA Medical Center
🇺🇸Hines, Illinois, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Harlem Hospital Center
🇺🇸New York, New York, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Chicago VA Medical Center (Lakeside)
🇺🇸Chicago, Illinois, United States
Columbia University/Presbyterian Medical Center
🇺🇸New York, New York, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
University of North Texas Health Science Center
🇺🇸Fort Worth, Texas, United States
Seattle King County Health Department
🇺🇸Seattle, Washington, United States
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, United States
LA County/USC Medical Center
🇺🇸Los Angeles, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Nashville VA Medical Center
🇺🇸Nashville, Tennessee, United States
Audi L. Murphy VA Hospital
🇺🇸San Antonio, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Denver Department of Public Health and Hospitals
🇺🇸Denver, Colorado, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Montreal Chest Institute McGill University
🇨🇦Montreal, Quebec, Canada