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Protocol 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
Gender: Male & Female
Min Age: 2
Max Age: 999

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Mycobacterium Tuberculosis;
Active Tuberculosis;
Latent Tuberculosis

Recruitment Keyword(s)

Tuberculosis;
TB

Condition(s)

Tuberculosis

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

- 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.

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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.

- Subjects enrolled will be able to provide informed consent for themselves, or if they lack the capacity to provide informed consent, the study team will comply with MAS M87.4, if the Principal Investigator believes there is the prospect of direct benefit for the patient.

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.

- Subjects that lack the capacity to provide informed consent autonomously are excluded; unless there is an appropriate legal guardian, Durable Power of Attorney (DPA) or surrogate who is willing to provide consent. A Bioethics consult will make this determination, based on an assessment of the patient and potential surrogate, in accordance with policy MAS M87-4.


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Citations:

Rosenzweig SD, Holland SM. Defects in the interferon-gamma and interleukin-12 pathways. Immunol Rev. 2005 Feb; 203:38-47.

Bellamy R, Ruwende C, Corrah T, McAdam KP, Whittle HC, Hill AV. Variations in the NRAMP1 gene and susceptibility to tuberculosis in West Africans. N Engl J Med. 1998 Mar 5; 338(10):640-4.

Flores-Villanueva PO, Ruiz-Morales JA, Song CH, Flores LM, Jo EK, Monta(SqrRoot) o M, Barnes PF, Selman M, Granados J. A functional promoter polymorphism in monocyte chemoattractant protein-1 is associated with increased susceptibility to pulmonary tuberculosis. J Exp Med. 2005 Dec 19; 202(12):1649-58. Epub 2005 Dec 13.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Steven M. Holland, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM B3-4233
10 CENTER DR
BETHESDA MD 20814
(301) 402-7684
sholland@mail.nih.gov

Steven M. Holland, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10-CRC RM B3-4233
10 CENTER DR
BETHESDA MD 20814
(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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