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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02639936
Other study ID # TBnet study #54
Secondary ID
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


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
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