New Generation IGRA in Immunocompromised Individuals (TBnet#54)

Tuberculosis Network European Trialsgroup

Status: Completed

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

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02639936

TBnet study #54

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,663 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals as specified for the study Population
• Written informed consent

Exclusion criteria

• <18 years of age

Trial design

2,663 participants in 6 patient groups

Immunocompetent controls

Description:

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

Solid organ transplant recipients

Description:

Patients after solid organ transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis

Stem cell transplant recipients

Description:

Patients after stem cell transplantation with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis

Patients with rheumatoid arthritis

Description:

Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis

Patients with chronic renal failure

Description:

Patients with chronic renal failure with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis

Individuals with HIV infection

Description:

Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis