Understanding the natural history of tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect blood and other samples from individuals with active or latent tuberculosis to investigate the natural history of the disease. Participants aged 2 years and older will undergo physical examinations and provide blood samples, with additional sputum and skin tissue samples collected from those with active TB. The study will also monitor the treatment of active TB patients and explore genetic and immune factors related to tuberculosis. The goal is to enhance understanding of TB pathogenesis and improve treatment strategies.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Steven M Holland, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Carla D Williams, R.N.
• Email: carla.williams@nih.gov
• Phone: (301) 443-9460

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.