Clinical trial NCT02639936: New Generation IGRA in Immunocompromised Individuals
Official title: Performance of a New Generation IGRA in Immunocompromised Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Tuberculosis Network European Trialsgroup
Sponsor class: NETWORK
First posted: 2015-12-28
Enrollment: 2663
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immunocompetent and immunocompromised patients

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Specificity
timeFrame: 2 years
measure: Sensitivity
timeFrame: 2 years
measure: Indeterminate results
timeFrame: 2 years
measure: Association with exposure
timeFrame: 2 years
measure: Progression
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kopenhagen
country: Denmark
facility: Rigshospitalet
city: Borstel
country: Germany
facility: Research center Borstel
city: Freiburg
country: Germany
facility: Freiburg University
city: Homburg
country: Germany
facility: Saarland University
city: Brescia
country: Italy
facility: University of Brescia and Brescia Spedali Civili General Hospital
city: Milano
country: Italy
facility: San Raffaele Scientific institute
city: Rome
country: Italy
facility: National Institute for Infectious Diseases L. Spallanzani
city: Chisinau
country: Moldova, Republic of
facility: Department of Pneumology & Allergology
city: Oslo
country: Norway
facility: Department of Infectious Diseases; Oslo University
city: Warszawa
country: Poland
facility: Warszawski Uniwersytet Medyczny
city: Vila Nova de Gaia
country: Portugal
facility: Centro de Diagnóstico Pneumológico
city: Bucharest
country: Romania
facility: Marius Nasta Institute of Pneumology
state: Sector 5
city: Badalona
country: Spain
facility: Institut d'Investigació Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: London
country: United Kingdom
facility: Department of Respiratory Medicine, Royal Free Hospital
Study officials:
affiliation: Universität des Saarlandes
name: Martina Sester, PhD
role: PRINCIPAL_INVESTIGATOR
References: