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New Generation IGRA in Immunocompromised Individuals (TBnet#54)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Tuberculosis Network European Trialsgroup

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

Condition or disease
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

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.
Study Design
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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
Groups and Cohorts
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Group/Cohort
Immunocompetent controls
Control persons without immunodeficiency with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
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
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
Patients with rheumatoid arthritis
Patients with rheumatoid arthritis with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis
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
Individuals with HIV infection
Individuals with HIV infection with and without active tuberculosis, with and without risk factors for prior exposure with M. tuberculosis


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Sensitivity [ Time Frame: 2 years ]
    The percentage of positive test results will be quantified among controls and patients with active tuberculosis.

  3. Indeterminate results [ Time Frame: 2 years ]
    The percentage of indeterminate results will be quantified in immunocompetent and immunocompromised patients

  4. Association with exposure [ Time Frame: 2 years ]
    Results from QFT-Plus assay will be associated with risk factors for M. tuberculosis exposure

  5. 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
Stimulated plasma samples

Eligibility Criteria
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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
Study Population
Immunocompetent and immunocompromised patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • <18 years of age
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Martina Sester, PhD 0049-6841-16 ext 23557 martina.sester@uks.eu

Locations
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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   
Sponsors and Collaborators
Tuberculosis Network European Trialsgroup
Investigators
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Principal Investigator: Martina Sester, PhD Universität des Saarlandes
More Information
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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
Additional relevant MeSH terms:
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Tuberculosis
Kidney Failure, Chronic
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic