Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01212003
Other study ID # 100195
Secondary ID 10-I-0195
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2011

Study information

Verified date April 9, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Carla D Williams, R.N.
Phone (301) 443-9460
Email carla.williams@nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 typically causes pneumonia, however dissemination to almost any other organ is possible. Drug resistance of the organism, co-infection with HIV, and paradoxical reactions upon treatment are all factors that may complicate treatment. Host defense against mycobacterial infections is important. Specific defects within the innate immune system lead to Mendelian susceptibility to mycobacterial infections. HIV infected individuals and persons treated with anti-tumor necrosis factor antibodies are highly susceptible to tuberculosis (TB) infection. Genetic influence on susceptibility to TB disease is complex and does not seem to be confined to a single gene or pathway. Advancement in molecular techniques has expanded our understanding of the pathogenesis and epidemiology of MTB. Identification of gene mutations that confer antibiotic resistance are being exploited as alternatives to conventional drug susceptibility testing. The natural history of all forms of TB disease (including co-infection with HIV and other infections) will be followed, and MTB isolates and blood from 100 infected patients will be obtained in order to study organism virulence and host immune function and genetic/epigenetic factors. While it is recognized that the number of TB cases that occur in the Washington, DC area and nationally is low, it is imperative that a mechanism is in place to evaluate and treat these patients at the NIH Clinical Center. This protocol will also allow NIH infectious diseases trainees to manage challenging cases of TB.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 2 Years to 100 Years
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rosenzweig SD, Holland SM. Defects in the interferon-gamma and interleukin-12 pathways. Immunol Rev. 2005 Feb;203:38-47. doi: 10.1111/j.0105-2896.2005.00227.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in the number of TB patients being actively followed at the NIH CC to provide information on TB patients with DS and drug-resistant disease for hypothesis generation and hands-on experience in the management of TB increased number of TB patients being actively followed at the NIH CC ongoing
Secondary Determination of subsets of lymphoid populations during various points in the treatment of TB subsets of lymphoid populations during various points in treatment of TB ongoing
Secondary Description of whole genome sequences and their possible relationship to TB infection possible relationship of whole genome sequences to TB infection ongoing
Secondary Collection of MTB specimens for studies of the organism and its pathogenesis collection of MTB specimens ongoing
See also
  Status Clinical Trial Phase
Recruiting NCT05738681 - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial Phase 2/Phase 3
Recruiting NCT05526885 - Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa N/A
Completed NCT04369326 - Community Initiated Preventive Therapy for TB N/A
Recruiting NCT04568967 - TB-CAPT EXULTANT - HIV N/A
Completed NCT02337270 - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol Phase 1
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Recruiting NCT04271397 - Immunological Biomarkers in Tuberculosis Management N/A
Withdrawn NCT03639038 - Tuberculosis Diagnosis by Flow Cytometry
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Recruiting NCT04975178 - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa Phase 3
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03973970 - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting NCT04230395 - Alcohol Reduction Among People With TB and HIV in India N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Active, not recruiting NCT02906007 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV Phase 1/Phase 2
Not yet recruiting NCT05917210 - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda N/A
Not yet recruiting NCT05845112 - Start Taking Action For TB Diagnosis
Not yet recruiting NCT06017843 - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding N/A
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT02781909 - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis Phase 2