Training Protocol on the Natural History of Tuberculosis
- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. However, most clinical studies of individuals with TB take place at international sites because there are many fewer cases of TB in the United States than elsewhere in the world. To provide better training for infectious disease staff members at the National Institutes of Health Clinical Center in Washington, D.C., researchers are interested in actively recruiting individuals with TB for research and treatment studies.
- To provide staff at the National Institutes of Health Clinical Center with increased experience in hands-on treatment of individuals with tuberculosis, including drug-sensitive or drug-resistant forms of the disease.
- To collect blood and other samples to study the natural history of tuberculosis.
- Individuals 2 years of age and older who have either active or latent tuberculosis.
- 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 will return for study visits every 2 months while receiving treatment, and will return every 6 months for 1 year after the end of treatment. Participants may be asked to return more often if researchers determine that additional care is needed to treat the infection.
|Study Design:||Time Perspective: Prospective|
- Develop on-site NIH Clinical Center (CC)/NIAID experience in the standard of care of tuberculosis patients with drug sensitive and drug resistant disease, as well as latent tuberculosis. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Characterize in vitro immune responses of patients with tuberculosis to a panel of agonists including but not limited to, strains of Mycobacterium tuberculosis (MTB), MTB antigens, and purified stimuli (e.g. Pam3Cys, LPS, HKLM). [ Time Frame: ongoing ] [ Designated as safety issue: No ]
- Characterize lymphoid profiles of patients with drug-sensitive (DS) TB, multi-drug resistant (MDR) TB, and extensively drug-resistant (XDR) TB both during acute, convalescent, and cured disease. [ Time Frame: ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
Mycobacterium tuberculosis is a slow-growing bacterium that establishes latent infection in millions of persons worldwide, but only leads to disease in 10% or less of these individuals. It typically causes pneumonia, however dissemination to almost any other organ is possible. Drug resistance of the organism, co-infection with HIV, and paradoxical reactions upon treatment are all factors that may complicate treatment.
Host defense against mycobacterial infections is important. Specific defects within the innate immune system lead to Mendelian susceptibility to mycobacterial infections. Human immunodeficiency virus (HIV) infected individuals and persons treated with anti-tumor necrosis factor antibodies are highly susceptible to tuberculosis 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 M. tuberculosis. 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 M. tuberculosis 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 tuberculosis 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 allow NIH infectious diseases trainees to manage challenging cases of tuberculosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212003
|Contact: Pamela A Welch, R.N.||(301) email@example.com|
|Contact: Steven M Holland, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Steven M Holland, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|