Training Protocol on the Natural History of Tuberculosis

NCT01212003 | Recruiting

• 2 other identifiers: 10019510-I-0195
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tuberculosis; Tuberculosis, Multidrug-Resistant; Latent Tuberculosis; Extensively Drug-Resistant Tuberculosis; Mycobacterium Infections

Keywords

TB; Mycobacterium Tuberculosis; Active Tuberculosis; Latent Tuberculosis; MDR TB; Natural History; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Determination of subsets of lymphoid populations during various points in the treatment of TB

  ongoing

• Description of whole genome sequences and their possible relationship to TB infection

  ongoing

• Collection of MTB specimens for studies of the organism and its pathogenesis

  ongoing

Study Arms (2)

Active TB

subjects with active TB as determined by smear, culture, or biopsy or have appropriately documented clinically suspicious active TB without definitive microbiology confirmation

Latent TB

subjects with 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

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be referred by their physicians for study participation. In many cases, participants will be referred by physicians at their local health department tuberculosis clinics (where they often receive DOT for TB treatment). Family members may be recruited through requests made by the index case that family members contact study personnel for participation. A patient can be referred at any time point while he or she is receiving active treatment for tuberculosis. Male and female patients will be accepted without preference. Patients age 2 and older are eligible; however, severe infections may require highly specialized pediatric teams and institutions. Some referrals of pediatric cases will not be able to be handled appropriately at the NIH and may be deemed ineligible for admission, as determined by the Principal Investigator (PI). NIH employees and members of their immediate families may participate in this protocol.

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• 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.
• Children: Children under the age of 2 are not eligible to enroll. The addition of the very young will not provide enough additional insights to justify the risk to this specific population.
• Pregnant women: Pregnant women are not eligible for participation in this protocol because the study objectives can be achieved without the enrollment of this population. Enrolled participants who become pregnant during the study will be withdrawn.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 15661020 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Mycobacterium Infections; Tuberculosis, Multidrug-Resistant; Latent Tuberculosis; Tuberculosis; Extensively Drug-Resistant Tuberculosis

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Steven M Holland, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla D Williams, R.N.

CONTACT

(301) 443-9460; carla.williams@nih.gov

Steven M Holland, M.D.

CONTACT

(301) 402-7684; sholland@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: June 30, 2011
• Last Updated: June 5, 2026

Record last verified: 2026-01-27

Locations

US (1)