New Generation IGRA in Immunocompromised Individuals

NCT02639936 | Completed

• 1 other identifier: TBnet study #54
• Study Type: observational
• Target: 2,663
• Locations: 10 countries
• Sites: 16

Brief Summary

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

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

Outcome Measures

Primary Outcomes (5)

• Specificity

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

  2 years

• Sensitivity

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

  2 years

• Indeterminate results

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

  2 years

• Association with exposure

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

  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

  4 years

Study Arms (6)

Immunocompetent controls

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

Solid organ transplant recipients

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Immunocompetent and immunocompromised patients

You may qualify if:

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

You may not qualify if:

• \<18 years of age

Sponsors & Collaborators

• Tuberculosis Network European Trialsgroup: lead

Study Sites (16)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Research center Borstel

Borstel, Germany

Location

Freiburg University

Freiburg im Breisgau, 79100, Germany

Location

Saarland University

Homburg, 66421, Germany

Location

University of Brescia and Brescia Spedali Civili General Hospital

Brescia, Italy

Location

San Raffaele Scientific institute

Milan, 20132, Italy

Location

National Institute for Infectious Diseases L. Spallanzani

Rome, 00149, Italy

Location

Department of Pneumology & Allergology

Chisinau, 2004, Moldova

Location

Department of Infectious Diseases; Oslo University

Oslo, 0450, Norway

Location

Warszawski Uniwersytet Medyczny

Warsaw, 02-097, Poland

Location

Centro de Diagnóstico Pneumológico

Vila Nova de Gaia, Portugal

Location

Marius Nasta Institute of Pneumology

Bucharest, Sector 5, 5, Romania

Location

Institut d'Investigació Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08001, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33001, Spain

Location

Department of Respiratory Medicine, Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

• Sester M, Altet-Gomez N, Andersen AB, Arias-Guillen M, Avsar K, Bakken Kran AM, Bothamley G, Nordholm Breschel AC, Brown J, Chesov D, Ciobanu N, Cirillo DM, Crudu V, de Souza Galvao M, Dilektasli AG, Dominguez J, Duarte R, Dyrhol-Riise AM, Goletti D, Hoffmann H, Ibraim E, Kalsdorf B, Krawczyk M, Kunst H, Lange B, Lipman M, Matteelli A, Milkiewicz P, Neyer D, Nitschke M, Oral HB, Palacios-Gutierrez JJ, Petruccioli E, Raszeja-Wyszomirska J, Ravn P, Rupp J, Spohn HE, Toader C, Villar-Hernandez R, Wagner D, van Leth F, Martinez L, Pedersen OS, Lange C. Diagnostic accuracy and predictive value of the QuantiFERON-TB gold plus assay for tuberculosis in immunocompromised individuals: a prospective TBnet study. Lancet Reg Health Eur. 2025 Aug 6;57:101416. doi: 10.1016/j.lanepe.2025.101416. eCollection 2025 Oct.

  PMID: 40823191 DERIVED

Related Links

• TBnet website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stimulated plasma samples

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Martina Sester, PhD

  Universität des Saarlandes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 28, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

ES (3); NO (1); PL (1); IT (3); DE (3); PT (1); RO (1); MO (1); GB (1); DK (1)