Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Centers for Disease Control and Prevention Department of Veterans Affairs |
---|---|
Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00023374 |
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.
Condition | Intervention |
---|---|
Tuberculosis |
Drug: Rifampin Drug: Pyrazinamide Drug: Ethambutol |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | TBTC Study 24: A Non-Comparative Study of the Efficacy of a Largely-Intermittent, Six-Month Tuberculosis Treatment Regimen Among Patients Who Will Not Receive Isoniazid Due to Initial Isoniazid Resistance or Intolerance |
Estimated Enrollment: | 98 |
Study Start Date: | August 2000 |
Estimated Study Completion Date: | July 2007 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Decision to discontinue or not use isoniazid for one or both of these following conditions within the first 70 days of therapy:
For patients enrolled after the start of therapy, documentation of adequate initial regimen as recommended in the CDC/ATS Treatment Guidelines (Appendix 1) is required. There are two means by which this requirement can be met:
A minimum duration of daily treatment as defined by one of two methods:
Following the minimum daily phase of therapy, adequate pre-enrollment treatment is defined as directly administered therapy given daily, twice weekly, or thrice weekly using CDC/ATS guidelines. Documenting pre-enrollment therapy is accomplished by hospital medical records and/or clinic entries of DOT.
Documentation of negative test for human immunodeficiency virus (HIV) infection. Documentation means written copies of HIV laboratory test results.
A negative HIV test result within the 6 months prior to enrollment is acceptable.
Documentation of study baseline laboratory parameters. Baseline laboratory parameters obtained no more than 2 weeks prior to enrollment and must be within the following limits:
Informed consent signed by patient and investigator documenting the willingness to use the 3-drug, intermittent regimen is required, in accordance with state law and local IRB requirements. Patients who are unable to provide informed consent due to an inability to comprehend English may be enrolled by providing informed consent by either of two means:
Exclusion criteria
United States, Arkansas | |
Central Arkansas Veterans Health System | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
LA County/USC Medical Center | |
Los Angeles, California, United States, 90033 | |
University of California, San Francisco | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver Department of Public Health and Hospitals | |
Denver, Colorado, United States, 80204 | |
United States, District of Columbia | |
Washington, D.C. VAMC | |
Washington, District of Columbia, United States, 20422 | |
United States, Illinois | |
Hines VA Medical Center | |
Hines, Illinois, United States, 60141 | |
Chicago VA Medical Center (Lakeside) | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins University School of Medicine | |
Baltimore, Maryland, United States, 21287-0003 | |
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, New Jersey | |
New Jersey Medical School | |
Newark, New Jersey, United States, 07107-3001 | |
United States, New York | |
New York University School of Medicine | |
New York, New York, United States, 10016 | |
Columbia University/Presbyterian Medical Center | |
New York, New York, United States, 10032 | |
Harlem Hospital Center | |
New York, New York, United States, 10037 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 34222 | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28203 | |
United States, Tennessee | |
Nashville VA Medical Center | |
Nashville, Tennessee, United States, 37212-2637 | |
United States, Texas | |
University of North Texas Health Science Center | |
Fort Worth, Texas, United States, 76107-2699 | |
Thomas Street Clinic | |
Houston, Texas, United States, 77009 | |
Audi L. Murphy VA Hospital | |
San Antonio, Texas, United States, 78284 | |
United States, Washington | |
Seattle King County Health Department | |
Seattle, Washington, United States, 98104 | |
Canada, British Columbia | |
University of British Columbia | |
Vancouver, British Columbia, Canada, Canada V5Z 4R4 | |
Canada, Manitoba | |
University of Manitoba | |
Winnipeg, Manitoba, Canada, CANADA R3A 1R8 | |
Canada, Quebec | |
Montreal Chest Institute McGill University | |
Montreal, Quebec, Canada, H2X 2P4Pq Canada |
Principal Investigator: | Randall Reves, MD | Denver Health and Hospitals, Denver CO |
Study ID Numbers: | CDC-NCHSTP-2340, 24 |
Study First Received: | September 6, 2001 |
Last Updated: | March 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00023374 History of Changes |
Health Authority: | United States: Federal Government |
tuberculosis TB isoniazid resistance isoniazid intolerance |
treatment efficacy toxicity |
Antimetabolites Bacterial Infections Anti-Bacterial Agents Rifampin Gram-Positive Bacterial Infections Antilipemic Agents |
Mycobacterium Infections Ethambutol Tuberculosis Antitubercular Agents Pyrazinamide Isoniazid |
Antimetabolites Bacterial Infections Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Pyrazinamide Actinomycetales Infections Pharmacologic Actions Anti-Bacterial Agents |
Gram-Positive Bacterial Infections Therapeutic Uses Mycobacterium Infections Tuberculosis Ethambutol Antitubercular Agents Fatty Acid Synthesis Inhibitors Isoniazid |