Active Tuberculosis Clinical Trial
— TBnet#54Official title:
Performance of a New Generation IGRA in Immunocompromised Individuals
Evaluation of a new ELISA based interferon-gamma release assay (QuantiFERON TB plus In-tube test) in immunocompromized patients
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Tuberculosis Network European Trialsgroup |
Denmark, Germany, Italy, Moldova, Republic of, Norway, Poland, Portugal, Romania, Spain, United Kingdom,
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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