Active Tuberculosis, Monitoring, Immunologic, Tuberculosis in Chronic Renal Failure, Tuberculosis in HIV-infected Individuals, Tuberculosis in Marrow Transplant Recipients, Tuberculosis in Rheumatoid Arthritis, Tuberculosis in Solid Organ Transplant Recipients
Conditions
Brief summary
Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients
Detailed description
This study is designed to evaluate the performance of a new ELISA based QuantiFERON-TB plus In-tube test to identify M. tuberculosis specific immune Responses as evidence of latent infection with M. tuberculosis in immunosuppressed populations. Both qualitative and quantitative test results will be related to the level of immunodeficiency and to the presence of risk factors for prior exposure with M. tuberculosis. In addition, patients with active tuberculosis (both immunocompetent and immunocompromised individuals) will be included to evaluate a potential increase in sensitivity in these groups. Immunocompetent individuals with low risk of exposure will be analysed as a proxy to estimate specificity. Finally, this study will be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.
Interventions
None listed
Sponsors
Tuberculosis Network European Trialsgroup
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals as specified for the study Population * Written informed consent
Exclusion criteria
* \<18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 2 years | The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure. |
| Sensitivity | 2 years | The percentage of positive test results will be quantified among controls and patients with active tuberculosis. |
| Indeterminate results | 2 years | The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients |
| Association with exposure | 2 years | Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure |
| Progression | 4 years | The number of individuals progressing to tuberculosis will be quantified depending on the test result at the time of screening and depending on preventive chemotherapy |
Countries
Denmark, Germany, Italy, Moldova, Norway, Poland, Portugal, Romania, Spain, United Kingdom
Outcome results
None listed