New Generation IGRA in Immunocompromised Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2663 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immunocompetent controls

Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis