RECRUITINGOBSERVATIONAL
Training Protocol on the Natural History of Tuberculosis
Natural History of Tuberculosis
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.
Who May Be Eligible (Plain English)
* Who May Qualify:
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 willing to sign a consent form for themselves or, if they lack the capacity to provide willing to sign a consent form, 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.
Who Should NOT Join This Trial:
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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
* 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.
Locations (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States