Status:
RECRUITING
Training Protocol on the Natural History of Tuberculosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Infections
Tuberculosis, Multidrug-Resistant
Eligibility:
All Genders
2-100 years
Brief Summary
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 stud...
Detailed Description
Mycobacterium tuberculosis (MTB) is a slow-growing bacterium that establishes latent infection in millions of persons worldwide, but only leads to disease in 10% or less of these individuals. It typic...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
June 30 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01212003
Start Date
June 30 2011
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892