Explore the NIHProtocol Details
Training Protocol on the Natural History of Tuberculosis
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
10-I-0195 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Mycobacterium Tuberculosis; |
Recruitment Keyword(s) |
Tuberculosis; |
Condition(s) |
Tuberculosis |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- 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.
Objectives:
- 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.
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 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.
Eligibility
INCLUSION CRITERIA:For All Patients
Patients may be included in this study who:
- Have a type of TB disease which, in the opinion of the Principal Investigator (PI), will assist in meeting the Primary Objective of this study (i.e., Develop experience in the standard of care of tuberculosis patients ).
- Are aged 2 years or older.
- Have a primary care physician, infectious diseases physician, pulmonologist, or tuberculosis 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.
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 PPD skin test or Interferon Gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)/CDC guidelines for latent TB (Appendix B); 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 tuberculosis of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.
- Have appropriately documented clinically suspicious active tuberculosis 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.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Steven M. Holland, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health BG 10-CRC RM B3-4233 MSC 1684 10 CENTER DR BETHESDA MD 20892-1684 (301) 402-7684 sholland@mail.nih.gov |
Steven M. Holland, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health BG 10-CRC RM B3-4233 MSC 1684 10 CENTER DR BETHESDA MD 20892-1684 (301) 402-7684 sholland@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01212003
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