RECRUITING

Training Protocol on the Natural History of Tuberculosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

Natural History of Tuberculosis

Quick Facts

Study Start:2011-06-30
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01212003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have or are suspected to have TB infection.
  2. * Are aged 2 years or older.
  3. * 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.
  4. * Are willing to consent to storage of specimens for future research.
  5. * 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).
  6. * Have active TB of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.
  7. * Have appropriately documented clinically suspicious active TB without definitive microbiology confirmation.
  1. * Are incarcerated.
  2. * Have been ordered by a court to take TB medications.
  3. * Are unwilling or unable to comply with prescribed therapy.
  4. * Are pregnant.

Contacts and Locations

Study Contact

Carla D Williams, R.N.
CONTACT
(301) 443-9460
carla.williams@nih.gov
Steven M Holland, M.D.
CONTACT
(301) 402-7684
sholland@mail.nih.gov

Principal Investigator

Steven M Holland, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Steven M Holland, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-06-30
Study Completion DateN/A

Study Record Updates

Study Start Date2011-06-30
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • TB
  • Mycobacterium Tuberculosis
  • Active Tuberculosis
  • Latent Tuberculosis
  • MDR TB
  • Natural History
  • Tuberculosis

Additional Relevant MeSH Terms

  • Mycobacterium Infections
  • Tuberculosis, Multidrug-Resistant
  • Latent Tuberculosis
  • Tuberculosis
  • Extensively Drug-Resistant Tuberculosis