TBTC NAA Study: Pilot Study of Surrogate Markers for Outcome of TB Treatment
Study of the Performance of Several Nucleic Acid Amplification Methodologies in the Diagnosis and Management of Active TB
2 other identifiers
observational
300
4 countries
14
Brief Summary
This is a pilot study to evaluate the performance of several nucleic acid amplification methodologies in the diagnosis and management of active tuberculosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 6, 2001
CompletedFirst Posted
Study publicly available on registry
September 10, 2001
CompletedAugust 3, 2011
June 1, 2011
September 6, 2001
August 2, 2011
Conditions
Keywords
Interventions
no intervention
Eligibility Criteria
pulmonary TB suspects
You may qualify if:
- (1) Enrollment in another TBTC treatment study, or (2) Suspected or culture-confirmed pulmonary TB (designated "NAA2"). Acceptable as indicators of suspected tuberculosis -- culture -- will be a positive AFB smear or a positive M. tuberculosis NAA test for MTB.
- (For NAA2 cases only): Collection of a sputum specimen for NAA processing, obtained in the interval from 14 days before, to 17 days after the start of anti-tuberculosis treatment.
- Physician recommendation and patient willingness to receive tuberculosis therapy as described in another TBTC treatment trial or in accordance with CDC/ATS recommendations as outlined below:
- Induction phase therapy will be initiated with 4-drugs (isoniazid, PZA, rifamycin and either ethambutol or streptomycin) by directly observed therapy (DOT).
- The induction regimen:
- Induction regimens must have at least 40 DOT doses (if daily) or at least 56 DOT daily dose equivalents (if twice weekly). No more than 2 of every 7 total doses may be self-administered. Total induction doses (both DOT and self-administered) should not exceed 70. Induction should be completed within 12 weeks
- The ethambutol or streptomycin may be discontinued if the patient continues on adequate induction therapy with INH, rifampin and PZA, and if the M. tuberculosis isolate is susceptible to INH and rifampin.
- If this induction regimen is not tolerated by the patient, a rifampin-containing regimen compatible with CDC/ATS recommendations is an acceptable alternative.
- Age 18 years or older
- Willingness to practice effective contraception (if female and of child-bearing potential)
- Provision of written informed consent. Signed by both the patient and investigator, in accordance with Institutional Review Board requirements
You may not qualify if:
- Treatment with a drug(s) with high anti-mycobacterial activity for more than 15 days in the two months PRIOR to the start of anti-tuberculosis treatment, unless co-enrolled in TBTC Study 23, TBTC Study 24 or another TBTC treatment study.
- Patients with only extrapulmonary tuberculosis, unless co-enrolled in TBTC Studies 23, TBTC Study 24, or another TBTC treatment study.
- Skeletal tuberculosis
- Silicotuberculosis
- Patient intolerance of rifamycins, or MTB resistance to rifamycins
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205, United States
LA County/USC Medical Center
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94110, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204, United States
Emory University School of Medicine
Atlanta, Georgia, 30303, United States
Chicago-Lakeside VAMC
Chicago, Illinois, 60611, United States
Harlem Hospital Center
New York, New York, 10037, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107-2699, United States
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284, United States
Seattle King County Health Department
Seattle, Washington, 98104, United States
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4, Canada
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8, Canada
Nelson R. Mandela School of Medicine
Durban, KwaZulu-Natal, South Africa
Makerere University Medical School
Kampala, Uganda
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Weiner, MD
Audie L. Murphy VA Hospital