TB study aims to unlock secrets of the disease
NCT ID NCT01212003
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 13 times
Summary
This study follows 150 people with active or latent tuberculosis (TB) to collect blood, sputum, and tissue samples. The goal is to better understand how TB behaves in the body and how the immune system responds. Participants receive standard TB treatment as part of the study, but no new drugs or therapies are being tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2011
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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2 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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