Trial record 5 of 15 for:    drug resistant AND NIAID | Open Studies | Exclude Unknown

Training Protocol on the Natural History of Tuberculosis

This study is currently recruiting participants.
Verified May 2013 by National Institutes of Health Clinical Center (CC)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: September 29, 2010
Last updated: March 14, 2014
Last verified: May 2013


- 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 Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Training Protocol on the Natural History of Tuberculosis

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: August 2010
Detailed Description:

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.


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.


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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01212003

Contact: Steven M Holland, M.D. (301) 402-7684

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   
Sponsors and Collaborators
Principal Investigator: Steven M Holland, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications: Identifier: NCT01212003     History of Changes
Other Study ID Numbers: 100195, 10-I-0195
Study First Received: September 29, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Mycobacterium Tuberculosis
Active Tuberculosis
Latent Tuberculosis

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on April 16, 2014