Tuberculosis Clinical Trial
Official title:
Natural History of Tuberculosis
NCT number | NCT01212003 |
Other study ID # | 100195 |
Secondary ID | 10-I-0195 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2011 |
Background: - 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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 100 Years |
Eligibility | - INCLUSION CRITERIA: FOR ALL PATIENTS 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 In addition to the above-described inclusion criteria for all patients, patients may be included in the Latent TB part of this protocol who: -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 In addition to the above-described inclusion criteria for all patients, patients may be included in the Active TB part of this protocol who: - 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: Patients will be excluded from this study who: - Are incarcerated. - Have been ordered by a court to take TB medications. - Are unwilling or unable to comply with prescribed therapy. - Are pregnant. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Increase in the number of TB patients being actively followed at the NIH CC to provide information on TB patients with DS and drug-resistant disease for hypothesis generation and hands-on experience in the management of TB | increased number of TB patients being actively followed at the NIH CC | ongoing | |
Secondary | Determination of subsets of lymphoid populations during various points in the treatment of TB | subsets of lymphoid populations during various points in treatment of TB | ongoing | |
Secondary | Description of whole genome sequences and their possible relationship to TB infection | possible relationship of whole genome sequences to TB infection | ongoing | |
Secondary | Collection of MTB specimens for studies of the organism and its pathogenesis | collection of MTB specimens | ongoing |
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