TB-NET - TB-NET #1

TB-NET #1

*TBNET - RESEARCH PROJECT #1*
	TIGRA in Immunocompromised PatientS

Titel:	TIGRA in immunocompromised individuals
PI:	Martina Sester e-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Corresponding author	Christoph Lange
Statistician:	Frank van Leth; Enrico Girardi
Status: April 2008	Ethics committee approval: Germany: Homburg (28.2.2008)
October 2008	Recruting patients

Summary:

Recently, novel in vitro assays termed T cell interferon-γ release assay (TIGRA) have become available that are based on the detection of interferon-γ (IFNγ) production in T cells or supernatants after stimulation with highly specific antigens of M. tuberculosis. Among these, the RD-1 encoded proteins ESAT-6 and CFP-10 are the ones best characterised and most widely used to identify specific immunity towards M. tuberculosis. It was found that a high percentage of M. tuberculosis infected persons had detectable cellular immune responses to these antigens in vitro. Thus, in vitro assays do not seem to be affected by BCG vaccination or exposure to most environmental mycobacteria that, similar to BCG, have lost RD-1 region during evolution. Moreover, available evidence suggests that TIGRA have an increased sensitivity in both immunocompetent individuals and immunocompromised patients such as HIV infected individuals, patients with chronic renal failure, and renal transplant recipients. Taken together, the in vitro assays are associated with a very high specificity and sensitivity and lack the need of a return visit as is required for the TST.

Two TIGRA are commercially available, the ELISPOT based T.SPOT.TB and the ELISA based QuantiFERON-TB Gold test (now available as an "IN-TUBE" version). Current evidence suggests that TIGRA based on cocktails containing ESAT-6 and CFP-10 have the potential to become useful diagnostic tools. It has, however, been shown, that rates of indeterminate and positive results may differ between both tests, suggesting that they might provide different results in routine clinical practice. Moreover, there is only inadequate evidence on the value of those TIGRA in the management of immunocompromised individuals. Based on the current literature and most recent meta-analyses, there is an urgent need for head-to-head comparative studies of the two commercially available tests in immunocompromised patients. This study is designed to carry out a head-to-head comparison of the T.SPOT.TB and the ELISA based QuantiFERON-TB Gold In-Tube test with the TST in immunosuppressed populations. In a second step that will be addressed at a later stage, this study may be extended to longitudinally assess the predictive value of a positive blood test for progression to active disease.

Downloadable File	Country / Language	Date
Study-Protocol	English	2008-02-13
Patient Information	Bulgarian English German Greek Italian Romanian Swedish Turkish	2008-03-10
Ethics committee approval	German: Homburg 28.02.2008 Freiburg 09.04.2008
Patient Form (Version: 080922)	PDF-Form

Recruting Centers:
Name	Country	Address/Institution
Rothel, Jim^#	^Australia	^{Chief Scientific Officer / Executive Director CELLESTIS LIMITED 1046A Dandenong Road, Carnegie VIC} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Markova, Roumiana}	^Bulgaria	^{MD, PhD, Assoc. Prof. Head Lab. Mediators of Inflammation and Immunity, Dept. Immunology and Allergology National Center of Infectious and Parasitic Diseases, 26 Yanko SakazovBlvd, Sofia 1504} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it , mark This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Ravn, Pernille}	^Denmark	^{MD, Phd. Dpt. of Infectious Diseases 144 Hvidovre Hospital, KettegÃ¥rds Alle 30, 2650 Hvidovre, Copenhagen} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Behrens, Frank}	^Germany	^{MD Rheumatology and Center for Drug Research, Development and Safety Johann Wolfgang Goethe - University D-60323 Frankfurt / Main} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Lange, Christoph+} ^{Ernst, Martin}	^Germany	^{MD PhD Div. of Clinical Infectious Diseases, Medical Clinic, Research Center Borstel Parkallee 35, 23845 Borstel} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Sester, Martina*} ^{Mack, Ulrich}	^Germany	^{PhD Department of Internal Medicine IV, University of the Saarland, 66421 Homburg} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}^{MD Department of Internal Medicine IV, University of the Saarland, 66421 Homburg} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Wagner, Dirk}	^Germany	^{MD Department of Infectious Diseases, University of Freiburg, 79106 Freiburg} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Wolf, Timo}	^Germany	^{MD HIV Treatment and Clinical Research Unit at the J.W.Goethe, University Hospital Frankfurt Theodor-Stern-Kai 7, 60590 Frankfurt am Main} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Gerogianni, Irini}	^Greece	^{PhD Respiratory Medicine, University of Thessaly Mezourlo-Larissa 41335} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Cirillo, Daniela} ^{Matteelli, Alberto}	^Italy	^{MD, PhD Emerging Bacterial Pathogens Unit, San Raffaele-Turro, Via Stamira Dâ€™Ancona 20,m 20127 Milan} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}^{MD Istituto Malattie Infettive e Tropicali, UniversitÃ degli Studi di Brescia Piazza Spedali Civili 1, 25123 Brescia} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Goletti, Delia} ^{Girardi, Enrico**}	^Italy	^{MD, PhD Clinical Investigator, Head of the Translational Research Unit of the Research Department Laboratorio del Vecchio, Room 13, National Institute for Infectious Diseases L. Spallanzani Via Portuense 292, Roma 00149} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it} ^{UOC Epidemiologia Clinica Istituto Nazionale Malattie Infettive L. Spallanzani â€“ IRCCS Via Portuense 292, 00149 Roma} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Migliori, Giovanni B.}	^Italy	^{MD Director, WHO Collaborating Center for TB and Lung Diseases Fondazione S. Maugeri, Care and Research Institute , Tradate, Italy} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Leth, Frank van**}	^Netherlands	^{MD, MSc, PhD Senior epidemiologist, KNCV Tuberculosis Foundation P.O. Box 146, 2501 CC The Hague} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Duarte, Raquel}	^Portugal	^{MD Centro de Diagnostico Pneumologico (CDP) de Vila Nova de Gaia} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Bumbacea, Dragos}	^Romania	^{MD, PhD, MPH Senior Lecturer, Clinica de Pneumologie, Marius Nasta Institute of Pneumology Carol Davila University of Medicine and Pharmacy, Bucharest} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Caliman-Sturdza, Olga}	^Romania	^{MD Department of Infectious Diseases, Emergency County Hospital "New St. John" Suceava 1 December 1918 Street, No.21, Suceava, 720203} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Dominguez, Jose}	^Spain	^{MD Servei de Microbiologia Hospital Univ. Germans Trias i Pujol. Badalona} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Bruchfeld, Judith}	^Sweden	^{MD Division of Infectious Diseases, Institution of Medicine, Karolinska Institute Huddinge University Hospital, Stockholm} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Janssens, Jean-Paul}	^Switzerland	^{MD Centre Antituberculeux, Hopital Cantonal Universitarie 1211 Geneva 14} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Eyuboglu, Fusun} ^{Dilektasli, Asli Gorek}	^Turkey	^{Badkent Universitesi Typ Fakueltesi, Goedues Hastalyklary Anabilim Daly Fevzi Ã‡akmak Bulvary 5. sokak No: 48, 06490 Bahcelievler, Ankara} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ^, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Yalcin, Aslihan}	^Turkey	^{Ankara University Medical Faculty Chest Diseases} This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
^{Lalvani, Ajit#}	^UK	^{MD, Professor of Infectious Diseases Tuberculosis Immunology Group, Department of Respiratory Medicine National Heart & Lung Institute, Wright Fleming Institute of Infection & Immunity Imperial College London, Norfolk Place, London W2 1PG} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{Milburn, Heather}	^UK	^{MSc MD FRCP, Consultant Physician, Senior Lecturer Chest Clinic, Guy's Hospital St Thomas' Street, London SE1 9RT} ^{This e-mail address is being protected from spam bots, you need JavaScript enabled to view it}
^{* not actively recruiting}	** statistitian

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