Training Protocol on the Natural History of Tuberculosis

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Observational

Phase

Not applicable / not listed

Age range

2 years - 100 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

150 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

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

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 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

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 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.

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.
• Are pregnant.

EXCLUSION OF SPECIFIC POPULATIONS

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.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study start

Jun 30, 2011 Actual

Primary completion

Not reported

Study completion

Not reported

First posted

Sep 30, 2010 Estimated

Last updated

Nov 10, 2026 Actual

Official study contacts