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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 Peter Donnelly (Study Coordinator) , ,
Kin Jip Cheung (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Peter De Burghgraeve (Data Manager) , EORTC Headquarters, Brussels
Angelique Deleersnijder (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Liv Meert (Data Manager) , EORTC Headquarters, Brussels
Marianne Paesmans (Statistician) , Institut Jules Bordet, Brussels
Laurens Vinckier (Pharmacovigilance Manager) , 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 CEDEX 9, France)
CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Gustave Roussy (VILLEJUIF CEDEX, France)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopitaux Universitaires de Strasbourg - Hautepierre (Strasbourg, France)
Masaryk University (Brno, Czech Republic)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitaetsklinikum Freiburg (Freiburg, Germany)
Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik I, II (Wuerzburg, Germany)
Protocol summary
NCT number NCT01288378
EudraCT 2010-020814-27
Financial Support Educational Grant