New Generation IGRA in Immunocompromised Individuals (TBnet#54)
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ClinicalTrials.gov Identifier: NCT02639936 |
Recruitment Status : Unknown
Verified August 2016 by Tuberculosis Network European Trialsgroup.
Recruitment status was: Recruiting
First Posted : December 28, 2015
Last Update Posted : August 9, 2016
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Condition or disease |
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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 |
Study Type : | Observational |
Estimated Enrollment : | 2000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Performance of a New Generation IGRA in Immunocompromised Individuals |
Study Start Date : | December 2015 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2019 |
Group/Cohort |
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Immunocompetent controls
Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
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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
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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
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Patients with rheumatoid arthritis
Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
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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
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Individuals with HIV infection
Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
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- Specificity [ Time Frame: 2 years ]The percentage of negative test results will be quantified among controls and patients without risk factors for M. tuberculosis exposure.
- Sensitivity [ Time Frame: 2 years ]The percentage of positive test results will be quantified among controls and patients with active tuberculosis.
- Indeterminate results [ Time Frame: 2 years ]The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients
- Association with exposure [ Time Frame: 2 years ]Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure
- Progression [ Time Frame: 4 years ]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
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Individuals as specified for the study Population
- Written informed consent
Exclusion Criteria:
- <18 years of age

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639936
Contact: Martina Sester, PhD | 0049-6841-16 ext 23557 | martina.sester@uks.eu |
Denmark | |
Rigshospitalet | Not yet recruiting |
Kopenhagen, Denmark, 2100 | |
Contact: Pernille Ravn, MD peravn@gmail.com | |
Contact: Christine Nordholm, MD christinenordholm@gmail.com | |
Sub-Investigator: Åse Bengaard Andersen, MD | |
Germany | |
Research center Borstel | Recruiting |
Borstel, Germany | |
Contact: Christoph Lange, MD PhD 49 4537 188 ext 3320 clange@fz-borstel.de | |
Contact: Barbara Kalsdorf, MD bkalsdorf@fz-borstel.de | |
Freiburg University | Recruiting |
Freiburg, Germany, 79100 | |
Contact: Berit Lange, MD berit.lange@uniklinik-freiburg.de | |
Contact: David Neyer dane86@gmx.net | |
Sub-Investigator: Dirk Wagner, MD | |
Saarland University | Recruiting |
Homburg, Germany, 66421 | |
Contact: Martina Sester, PhD 0049-6841-16 ext 23557 martina.sester@uks.eu | |
Italy | |
University of Brescia and Brescia Spedali Civili General Hospital | Recruiting |
Brescia, Italy | |
Contact: Alberto Matteelli, MD +39 030 399 ext 5802 alberto.matteelli@unibs.it | |
San Raffaele Scientific institute | Recruiting |
Milano, Italy, 20132 | |
Contact: Daniela M Cirillo, MD PhD +393333124 ext 713 cirillo.daniela@hsr.it | |
National Institute for Infectious Diseases L. Spallanzani | Recruiting |
Rome, Italy, 00149 | |
Contact: Delia Goletti, MD PhD delia.goletti@inmi.it | |
Moldova, Republic of | |
Department of Pneumology & Allergology | Not yet recruiting |
Chisinau, Moldova, Republic of, 2004 | |
Contact: Dumitru Chesov, MD +373 69961788 dumitru.chesov@usmf.md | |
Norway | |
Department of Infectious Diseases; Oslo University | Recruiting |
Oslo, Norway, 0450 | |
Contact: Anne Margarita Dyrhol-Riise, MD 4792857261 a.m.d.riise@medisin.uio.no | |
Poland | |
Warszawski Uniwersytet Medyczny | Recruiting |
Warszawa, Poland, 02-097 | |
Contact: Marcin Krawczyk, MD 0049 22 11 66 189 Marcin.Krawczyk@uniklinikum-saarland.de | |
Portugal | |
Centro de Diagnóstico Pneumológico | Recruiting |
Vila Nova de Gaia, Portugal | |
Contact: Raquel Duarte, MD PhD 35122375 ext 5599 raquelafduarte@gmail.com | |
Romania | |
Marius Nasta Institute of Pneumology | Recruiting |
Bucharest, Sector 5, Romania, 5 | |
Contact: Elmira Ibrahim, MD 40 21 335 69 10 ext 1527 ielmira2000@yahoo.com | |
Spain | |
Institut d'Investigació Germans Trias i Pujol | Not yet recruiting |
Badalona, Spain, 08916 | |
Contact: José Domínguez, MD +34 93 497 86 97 jadomb@gmail.com | |
Sub-Investigator: Neus Altet, MD | |
Hospital Universitari Vall d'Hebron | Recruiting |
Barcelona, Spain, 08001 | |
Contact: Malú de Souza Galvão, MD 34 93 301 24 24 maludesouzagalvao@gmail.com | |
Hospital Universitario Central de Asturias | Recruiting |
Oviedo, Spain, 33001 | |
Contact: Miguel Arias Guillen, MD 0034 985108043 miguelariasguillen@gmail.com | |
United Kingdom | |
Department of Respiratory Medicine, Royal Free Hospital | Recruiting |
London, United Kingdom, NW3 2QG | |
Contact: Lipman Marc, MD 02074726260 marclipman@nhs.net | |
Contact: Brown James, MD 02074726260 james.brown13@nhs.net |
Principal Investigator: | Martina Sester, PhD | Universität des Saarlandes |
Responsible Party: | Tuberculosis Network European Trialsgroup |
ClinicalTrials.gov Identifier: | NCT02639936 |
Other Study ID Numbers: |
TBnet study #54 |
First Posted: | December 28, 2015 Key Record Dates |
Last Update Posted: | August 9, 2016 |
Last Verified: | August 2016 |
Tuberculosis Kidney Failure, Chronic Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Renal Insufficiency Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |