TBTC NAA Study: Pilot Study of Surrogate Markers for Outcome of TB Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023439
First received: September 6, 2001
Last updated: August 2, 2011
Last verified: June 2011
  Purpose

This is a pilot study to evaluate the performance of several nucleic acid amplification methodologies in the diagnosis and management of active tuberculosis


Condition Intervention
Tuberculosis
Other: Nucleic Acid Amplification Methods for diagnosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of the Performance of Several Nucleic Acid Amplification Methodologies in the Diagnosis and Management of Active TB

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Estimated Enrollment: 300
Study Start Date: May 2000
Intervention Details:
    Other: Nucleic Acid Amplification Methods for diagnosis
    no intervention
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pulmonary TB suspects

Criteria

Inclusion Criteria:

  1. (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.
  2. (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.
  3. 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:

      1. 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
      2. 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.
  4. Age 18 years or older
  5. Willingness to practice effective contraception (if female and of child-bearing potential)
  6. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023439

Locations
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, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
Chicago-Lakeside VAMC
Chicago, Illinois, United States, 60611
United States, New York
Harlem Hospital Center
New York, New York, United States, 10037
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107-2699
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
South Africa
Nelson R. Mandela School of Medicine
Durban, KwaZulu Natal, South Africa
Uganda
Makerere University Medical School
Kampala, Uganda
Sponsors and Collaborators
Investigators
Principal Investigator: Marc Weiner, MD Audie L. Murphy VA Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Stefan Goldberg, CDC
ClinicalTrials.gov Identifier: NCT00023439     History of Changes
Other Study ID Numbers: CDC-NCHSTP-2530, NAA TBTC
Study First Received: September 6, 2001
Last Updated: August 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
tuberculosis
TB

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014