Training Protocol on the Natural History of Tuberculosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-100
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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....

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Are incarcerated.

Have been ordered by a court to take TB medications.

Are unwilling or unable to comply with prescribed therapy.

Are pregnant.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Active TB
Group B: Latent TB

Trial outcomes

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

Time frame
ongoing

Secondary outcomes

1

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

subsets of lymphoid populations during various points in treatment of TB

Time frame
ongoing
2

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

possible relationship of whole genome sequences to TB infection

Time frame
ongoing
3

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

collection of MTB specimens

Time frame
ongoing

Other outcomes

Sponsors and contacts

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