New Generation IGRA in Immunocompromised Individuals

Tuberculosis Network European Trialsgroup2,663 enrolled

Overview

Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients

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.

Study Type

OBSERVATIONAL

Enrollment

2,663

Conditions

Monitoring, Immunologic Active Tuberculosis Tuberculosis in Solid Organ Transplant Recipients Tuberculosis in Marrow Transplant Recipients Tuberculosis in Rheumatoid Arthritis Tuberculosis in Chronic Renal Failure Tuberculosis in HIV-infected Individuals

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals as specified for the study Population * Written informed consent Exclusion Criteria: * \<18 years of age

Locations (16)

Rigshospitalet

Copenhagen, Denmark

Research center Borstel

Borstel, Germany

Freiburg University

Outcomes

Primary Outcomes

Specificity

The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.

Time frame: 2 years

Sensitivity

The percentage of positive test results will be quantified among controls and patients with active tuberculosis.

Time frame: 2 years

Indeterminate results

The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients

Time frame: 2 years

Association with exposure

Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure

Time frame: 2 years

Progression

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

Time frame: 4 years

Data from ClinicalTrials.gov

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