Training Protocol on the Natural History of Tuberculosis

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Sep 29, 2010

Keywords

ClinConnect Summary

This clinical trial is focused on understanding tuberculosis (TB), an infectious disease that affects many people around the world. The researchers want to learn more about how TB develops and progresses by collecting blood and other samples from individuals who either have active TB or latent TB (which means they have been infected but do not show symptoms). The goal is to gather information that can help improve treatments and care for those with this disease.

To participate in this study, individuals aged 2 years and older who have been diagnosed with TB or are suspected of having it may be eligible. Participants with latent TB will attend a single visit where they will undergo a physical examination and provide blood samples. Those with active TB will have an initial visit with a similar examination, and they might also need to provide sputum (mucus) samples and possibly a small skin tissue sample. Active TB patients will receive treatment as part of the study and may need to return for follow-up visits every 1-2 months during their treatment. It’s important to note that participants must have a healthcare provider outside the study to help manage their TB care. If you or someone you know is interested in this trial, it could be a valuable opportunity to contribute to important research on tuberculosis.

Gender

ALL

Eligibility criteria

• * 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.