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Empirical versus pre-emptive (diagnostic-driven) antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase III strategy study of the EORTC Infectious Diseases and Leukemia Groups

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 08-Mar-2012
Date Step1 close: 30-Sep-2015
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 556 - All Groups: 556
Treatment Drug
Study Staff Kin Jip Cheung (Senior Clinical Operations Manager) kin-jip.cheung (at), EORTC Headquarters, Brussels
Peter De Burghgraeve (Data Manager) peter.deburghgraeve (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Liv Meert (Data Manager) liv.meert (at), EORTC Headquarters, Brussels
Marianne Paesmans (Statistician) , Institut Jules Bordet-Hopital Universitaire ULB, Brussels
Laurens Vinckier (Pharmacovigilance Manager) laurens.vinckier (at), EORTC Headquarters, Brussels
Type of cancer Acute Myelogenous Leukemia
Myelodysplastic Syndroms
Infectious Disease : Fungal
Participating groups EORTC Leukemia Group
EORTC Infectious Diseases Group
Recruiting centers A.Z. St. Jan (Brugge, Belgium)
Assistance Publique - Hopitaux de Paris - CHU Henri Mondor (Creteil, France)
C.H.U. Sart-Tilman (Liege, Belgium)
CHRU de Lille - Hopital Huriez (Lille, France)
CHU de Caen - Hopital Cote de Nacre (Caen, France)
CHU de Limoges - Hopital Dupuytren (Limoges, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Gustave Roussy (Villejuif, France)
Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Klinikum der Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany)
Masaryk University (Brno, Czech Republic)
National Cancer Institute (Bratislava, Slovakia)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitaetsklinikum Freiburg (Freiburg, Germany)
Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II (Wuerzburg, Germany)
Centers to be activated Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine (Udine, Italy)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Gustave Roussy (Villejuif, France)
Hacettepe University School of Medicine (Ankara, Turkey)
IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro (Genova, Italy)
University Hospital Centre Zagreb (Zagreb, Croatia)
Protocol summary
NCT number NCT01288378
EudraCT 2010-020814-27