Latent Tuberculosis Clinical Trial
Official title:
Risk Stratification in Latent Tuberculosis: PET/CT Findings in TB Contacts
Background:
- Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB
bacteria but have not become sick are said to have latent TB. Many people with latent TB will
not get sick from it, but some people will develop active TB and become sick. Much is known
about how to treat and diagnose active TB, but little is known about the best way to treat
latent TB. Researchers also want to know more about the risk that latent TB will develop into
active TB, and whether it is possible to test for this risk.
Objectives:
- To test possible methods of determining a person s risk for developing active TB.
Eligibility:
- Individuals between 20 and 60 years of age who (1) have active TB, (2) were exposed to
someone with active TB in the past 9 months, or (3) have not been exposed to TB.
Design:
- Participants will be separated into groups based on their exposure to TB.
- Healthy participants who were not exposed to TB will answer questions about their
medical history. They will also provide blood and urine samples.
- Participants who have active TB will have a physical exam and medical history. They will
provide blood, urine, and sputum samples, and will have a chest x-ray. They will be
treated with the standard of care for active TB. Some participants with active TB may
have additional tests as part of this study.
- Participants who were exposed to TB and have latent TB will have a physical exam and
medical history. They will provide blood, urine, and sputum samples, and will have a
chest x-ray. They will be asked to return for five more clinic visits over the next 12
months to repeat these tests. They may also have additional chest imaging studies
depending on the study needs.
- Some of the exposed participants may have been exposed to drug-resistant TB. These
participants will receive the drug isoniazid to take on a regular schedule to help
prevent the latent TB from becoming active TB.
The efficacy of treating tuberculin skin test (TST) positive, or interferon gamma release
assay (IGRA) positive, contacts of tuberculosis (TB) cases to prevent progression to disease
is well established. However the length of treatment, and the toxicity associated with the
currently used regimens, means that the risk may outweigh the benefit and treatment
completion rates are poor. In addition, no proven regimens are available for contacts of
multidrug resistant tuberculosis (MDR-TB) cases. Because as few as 2% of contacts develop
active TB over 1 year and no surrogate markers are available, drug trials to assess novel
treatments typically require thousands of subjects followed up for many years.
(18F)-fluoro-2-deoxy-D-glucose positron emission tomography/computer tomography (FDG-PET/CT)
may prove a useful surrogate for more targeted chemoprophylaxis as well as a means to rapidly
evaluate novel prophylactic regimes in future studies.
Up to 40% of immune-sensitized TB contacts with normal chest radiographs (CXR) have
abnormalities on conventional chest CT. FDG-PET/CT not only will allow characterization of
the metabolic activity of these lesions but is also likely to reveal significantly increased
metabolic activity within regional lymph nodes that may otherwise be anatomically normal.
Based on previous studies, we predict that up to 65% of contacts will have combined chest
PET/CT abnormalities and that up to 50% of contacts who are treated, will have increased FDG
uptake that will resolve with treatment. By contrast, PET screening studies demonstrate
abnormal pulmonary FDG uptake occurs in 0.9% of healthy individuals.
The development of biomarkers more predictive of disease progression is also highly
desirable, but for similar reasons evaluating them is challenging. This novel approach of
using FDG-PET/CT to benchmark the dynamic immunological, transcriptional, or metabolic
changes that occur early in tuberculosis infection, we hope will accelerate biomarker
discovery. In this study we propose to evaluate these predictions in order to lay the
foundation for future studies.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05073926 -
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
|
||
Not yet recruiting |
NCT04428294 -
Impact of LTBI Treatment on Glucose Tolerance and Chronic Inflammation
|
Phase 4 | |
Completed |
NCT02276755 -
Vitamin D Supplementation in TB Prevention
|
Phase 3 | |
Withdrawn |
NCT03498534 -
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
|
Phase 4 | |
Active, not recruiting |
NCT03988933 -
2R2: Higher Dose Rifampin for 2 Months vs Standard Dose Rifampin for Latent TB.
|
Phase 2 | |
Recruiting |
NCT06022146 -
TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts
|
Phase 3 | |
Active, not recruiting |
NCT04188041 -
Improving Rhode Island's Tuberculosis Preventive Services in Primary Care
|
N/A | |
Recruiting |
NCT03730181 -
Tuberculosis Clinical Trials Consortium Study 35
|
Phase 1/Phase 2 | |
Completed |
NCT01967134 -
Safety and Immunogenicity Study of AERAS-456 Vaccine for Tuberculosis
|
Phase 1 | |
Completed |
NCT00257907 -
Immune Response to Mycobacterium Tuberculosis Infection
|
||
Recruiting |
NCT05756582 -
Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students
|
||
Active, not recruiting |
NCT04557176 -
TB Screening Improves Preventive Therapy Uptake
|
N/A | |
Completed |
NCT02119130 -
Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa
|
N/A | |
Not yet recruiting |
NCT06281834 -
Dolutegravir Pharmacokinetics During Weekly Rifapentine/Isoniazid for TB Prevention
|
Phase 1 | |
Not yet recruiting |
NCT02512484 -
Improving the Detection of Active Tuberculosis in Accident and Emergency Departments
|
N/A | |
Completed |
NCT00763295 -
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
|
N/A | |
Completed |
NCT01850043 -
The Epidemiology of TST Change in Korea
|
N/A | |
Completed |
NCT02090374 -
Development of Human Nasal Challenge Models With Microbial Constituents and Grass Pollen
|
N/A | |
Completed |
NCT02073669 -
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults
|
N/A | |
Completed |
NCT02880982 -
Trial of Vitamin D Supplementation in Cape Town Primary Schoolchildren
|
Phase 3 |