New Generation IGRA in Immunocompromised Individuals

Active Tuberculosis Clinical Trial

— TBnet#54  

Official title:

Performance of a New Generation IGRA in Immunocompromised Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02639936
• Other study ID #: TBnet study #54
• Status: Recruiting
• Phase: N/A
• First received: December 15, 2015
• Last updated: August 5, 2016
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Tuberculosis Network European Trialsgroup
• Contact: Martina Sester, PhD
• Phone: 0049-6841-16
• Email: martina.sester[@]uks.eu
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals as specified for the study Population

• Written informed consent

Exclusion Criteria:

• <18 years of age

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Kopenhagen
Germany	Research center Borstel	Borstel
Germany	Freiburg University	Freiburg
Germany	Saarland University	Homburg
Italy	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
Moldova, Republic of	Department of Pneumology & Allergology	Chisinau
Norway	Department of Infectious Diseases; Oslo University	Oslo
Poland	Warszawski Uniwersytet Medyczny	Warszawa
Portugal	Centro de Diagnóstico Pneumológico	Vila Nova de Gaia
Romania	Marius Nasta Institute of Pneumology	Bucharest	Sector 5
Spain	Institut d'Investigació Germans Trias i Pujol	Badalona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Central de Asturias	Oviedo
United Kingdom	Department of Respiratory Medicine, Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Tuberculosis Network European Trialsgroup

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Moldova, Republic of,  Norway,  Poland,  Portugal,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity	The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.	2 years	No
Primary	Sensitivity	The percentage of positive test results will be quantified among controls and patients with active tuberculosis.	2 years	No
Primary	Indeterminate results	The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients	2 years	No
Primary	Association with exposure	Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure	2 years	No
Primary	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	No

External Links

•   TBnet website