Actively Recruiting

Age: 2Years - 100Years
All Genders
ID01212003

Natural History of Tuberculosis Study to Understand Active and Latent TB Infections and Treatments

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-05

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying tuberculosis (TB), a widespread infectious disease caused by Mycobacterium tuberculosis. The study aims to understand the natural history of TB, including active and latent infections, and to explore factors like drug resistance, co-infections such as HIV, and genetic influences on susceptibility. The research is important for improving knowledge about TB disease progression and treatment complications. Participants with latent TB will have one study visit involving a physical exam, medical history, and blood samples. Those with active TB will have an initial visit with similar assessments plus sputum samples and an optional skin biopsy. Active TB patients will receive treatment as part of the study and may have follow-up visits every 1 to 2 months during treatment. During the study, participants will undergo physical examinations, medical history reviews, and provide blood and sputum samples for testing and research. Researchers will analyze immune responses, genetic factors, and bacterial characteristics. The study will track active TB patients over time to gain insights into treatment and disease outcomes. The total duration varies, with latent TB participants having a single visit and active TB participants being monitored during treatment.

CONDITIONS

Brief Title

Training Protocol on the Natural History of Tuberculosis

Who Can Participate

Age: 2Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have or are suspected to have tuberculosis infection
  • Are aged 2 years or older
  • Have a healthcare provider experienced in TB care outside the NIH
  • Are willing to consent to storage of specimens for future research
  • Able to provide informed consent personally or via a legally authorized representative
  • For latent TB: documented positive PPD skin test or IGRA test meeting ATS/CDC guidelines
  • For active TB: confirmed or clinically suspected active TB of any drug susceptibility and any infection site
Not Eligible

You will not qualify if you...

  • Currently incarcerated
  • Court-ordered to take TB medications
  • Unwilling or unable to comply with prescribed therapy
  • Pregnant or become pregnant during the study
  • Children under 2 years of age are not eligible

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Ongoing throughout the study period

Participants with active or latent tuberculosis are observed to follow the natural history of TB, including collection of samples and clinical data to study disease progression and host response.

Visits scheduled as part of routine care; additional assessments may occur depending on participant status

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

C

Carla D Williams, R.N.

S

Steven M Holland, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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