NCT01212003 Training Protocol on the Natural History of Tuberculosis
| NCT ID | NCT01212003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Mycobacterium Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2011-06-30 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2011-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
* 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.
Contact & Investigator
Steven M Holland, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT01212003 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 100 Years, studying Mycobacterium Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01212003 currently recruiting?
Yes, NCT01212003 is actively recruiting participants. Contact the research team at carla.williams@nih.gov for enrollment information.
Where is the NCT01212003 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01212003 clinical trial?
NCT01212003 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Steven M Holland, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 150 participants.