Training Protocol on the Natural History of Tuberculosis
NCT ID: NCT01212003
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2011-06-30
Brief Summary
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\- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.
Objectives:
\- To collect blood and other samples to study the natural history of tuberculosis.
Eligibility:
\- Individuals 2 years of age and older who have either active or latent tuberculosis.
Design:
* Latent TB patients: Participants will have a single study visit with a physical examination and medical history, and will provide blood samples for testing.
* Active TB patients: Participants will have an initial visit with a physical examination and medical history, and will provide blood samples for testing. Participants will also provide sputum samples if required, and may have an optional skin punch biopsy to collect a sample of skin tissue for study.
* Treatment for active TB will be provided as part of this protocol.
* Active TB participants may be asked to return for study visits every 1-2 months while receiving treatment.
Detailed Description
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Host defense against mycobacterial infections is important. Specific defects within the innate immune system lead to Mendelian susceptibility to mycobacterial infections. HIV infected individuals and persons treated with anti-tumor necrosis factor antibodies are highly susceptible to tuberculosis (TB) infection. Genetic influence on susceptibility to TB disease is complex and does not seem to be confined to a single gene or pathway.
Advancement in molecular techniques has expanded our understanding of the pathogenesis and epidemiology of MTB. Identification of gene mutations that confer antibiotic resistance are being exploited as alternatives to conventional drug susceptibility testing.
The natural history of all forms of TB disease (including co-infection with HIV and other infections) will be followed, and MTB isolates and blood from 100 infected patients will be obtained in order to study organism virulence and host immune function and genetic/epigenetic factors. While it is recognized that the number of TB cases that occur in the Washington, DC area and nationally is low, it is imperative that a mechanism is in place to evaluate and treat these patients at the NIH Clinical Center. This protocol will also allow NIH infectious diseases trainees to manage challenging cases of TB.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Active TB
subjects with active TB as determined by smear, culture, or biopsy or have appropriately documented clinically suspicious active TB without definitive microbiology confirmation
No interventions assigned to this group
Latent TB
subjects with documented evidence of a positive PPD skin test or Interferon Gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)/CDC guidelines for latent TB
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Patients may be included in this study who:
* Have or are suspected to have TB infection.
* Are aged 2 years or older.
* Have a primary care physician, infectious diseases physician, pulmonologist, or TB specialist outside of the NIH who can provide care of his or her TB infection outside the NIH, provide directly observed therapy (DOT) if necessary, and monitor for side effects and toxicity of TB medications.
* Are willing to consent to storage of specimens for future research.
* Able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, have an appropriate Legally Authorized Representative (LAR; the study team will comply with NIH Human Research Protection Program \[HRPP\] Policy 403).
FOR PATIENTS WITH LATENT TB
-Have documented evidence of a positive purified protein derivative (PPD) skin test or Interferon-gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)/CDC guidelines for latent TB; conversion can have occurred at any time.
FOR PATIENTS WITH ACTIVE TB
* Have active TB of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.
* Have appropriately documented clinically suspicious active TB without definitive microbiology confirmation.
Exclusion Criteria
* Are incarcerated.
* Have been ordered by a court to take TB medications.
* Are unwilling or unable to comply with prescribed therapy.
* Are pregnant.
2 Years
100 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Steven M Holland, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Carla Williams, B.S.N.
Role: primary
References
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Rosenzweig SD, Holland SM. Defects in the interferon-gamma and interleukin-12 pathways. Immunol Rev. 2005 Feb;203:38-47. doi: 10.1111/j.0105-2896.2005.00227.x.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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10-I-0195
Identifier Type: -
Identifier Source: secondary_id
100195
Identifier Type: -
Identifier Source: org_study_id