New Generation IGRA in Immunocompromised Individuals

Completed

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

• Registration Number: NCT02639936
• Lead Sponsor: Tuberculosis Network European Trialsgroup

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Primary Completion: 2023-12
• Study Completion: 2023-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2663

Inclusion Criteria

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

Exclusion Criteria

• <18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	2 years	The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
Specificity	2 years	The percentage of negative test results will be quantified among controls and patients without 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
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

Trial Locations

Locations (16)

Rigshospitalet; 🇩🇰 Kopenhagen, Denmark

Research center Borstel; 🇩🇪 Borstel, Germany

Freiburg University; 🇩🇪 Freiburg, Germany

Saarland University; 🇩🇪 Homburg, Germany

University of Brescia and Brescia Spedali Civili General Hospital; 🇮🇹 Brescia, Italy

San Raffaele Scientific institute; 🇮🇹 Milano, Italy

National Institute for Infectious Diseases L. Spallanzani; 🇮🇹 Rome, Italy

Department of Pneumology & Allergology; 🇲🇩 Chisinau, Moldova, Republic of

Department of Infectious Diseases; Oslo University; 🇳🇴 Oslo, Norway

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Warszawski Uniwersytet Medyczny; 🇵🇱 Warszawa, Poland

Centro de Diagnóstico Pneumológico; 🇵🇹 Vila Nova de Gaia, Portugal

Marius Nasta Institute of Pneumology; 🇷🇴 Bucharest, Sector 5, Romania

Institut d'Investigació Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Department of Respiratory Medicine, Royal Free Hospital; 🇬🇧 London, United Kingdom