- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00023439
TBTC NAA Study: Pilot Study of Surrogate Markers for Outcome of TB Treatment
August 2, 2011 updated by: Centers for Disease Control and Prevention
Study of the Performance of Several Nucleic Acid Amplification Methodologies in the Diagnosis and Management of Active TB
This is a pilot study to evaluate the performance of several nucleic acid amplification methodologies in the diagnosis and management of active tuberculosis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study evaluates potential surrogate markers of treatment failure and relapse as a substudy of ongoing Tuberculosis Trials Consortium (TBTC) disease treatment studies.
After enrollment is complete, specimens from cases of treatment failure and relapse will be evaluated in comparison to control samples to measure the prognostic value of the following tests: 1) quantitative rRNA in 2-month sputum to predict relapse, 2) MTB 85B mRNA to detect reactivation, 3) 1- to 4-month NAA and broth culture tests to predict relapse, 4) mRNA, rRNA and DNA at and after end of therapy to predict relapse, 5)sputum rRNA and blood DNA to detect recurrence during prodrome, 6) sputum rRNA compared to cultures to diagnose "paradoxical reactions," 7) compare blood DNA to cultures at end of induction and end of treatment, 8) compare accuracies of different NAA assays and standard cultures, 9) determine MTD rRNA assay positive to negative conversion time, 10) characterize quality and quantity of sputum over time in relation to culture and clinical outcome, 11) assess ability of clinical, radiographic, and microbiologic risk factors to predict treatment failure and relapse.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, Canada V5Z 4R4
- University of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, CANADA R3A 1R8
- University of Manitoba
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KwaZulu Natal
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Durban, KwaZulu Natal, South Africa
- Nelson R. Mandela School of Medicine
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Kampala, Uganda
- Makerere University Medical School
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Central Arkansas Veterans Health System
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California
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Los Angeles, California, United States, 90033
- LA County/USC Medical Center
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San Francisco, California, United States, 94110
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80204
- Denver Department of Public Health and Hospitals
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University School of Medicine
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Illinois
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Chicago, Illinois, United States, 60611
- Chicago-Lakeside VAMC
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New York
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New York, New York, United States, 10037
- Harlem Hospital Center
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Texas
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Fort Worth, Texas, United States, 76107-2699
- University of North Texas Health Science Center
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San Antonio, Texas, United States, 78284
- Audi L. Murphy VA Hospital
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Washington
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Seattle, Washington, United States, 98104
- Seattle King County Health Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pulmonary TB suspects
Description
Inclusion Criteria:
- (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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marc Weiner, MD, Audie L. Murphy VA Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2000
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
September 6, 2001
First Submitted That Met QC Criteria
September 8, 2001
First Posted (Estimate)
September 10, 2001
Study Record Updates
Last Update Posted (Estimate)
August 3, 2011
Last Update Submitted That Met QC Criteria
August 2, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-2530
- NAA TBTC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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