320
Participants
Start Date
February 11, 2019
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2025
Posaconazole
Posaconazole is a triazole with broad-spectrum activity, to include Candida species, Aspergillus species, and other fungal pathogens, including the Zygomycetes. Posaconazole is available as slow release tablets (300mg/day) and as intravenous (IV) formulation (300mg/day) and is licensed and approved in Switzerland for the prevention of IFI, including mold and yeast infections, in patients \>18 years who are at high risk of developing these types of infection (patients with long-term neutropenia or HCT recipients). Furthermore, international guidelines recommend posaconazole for primary antifungal prophylaxis in high-risk patients, such as AML patients with prolonged neutropenia. Posaconazole is available in Switzerland under the name of Noxafil® in capsules of 100mg, suspension of 40mg/mL and intravenous formulation of 300mg/16.7 mL.
Fluconazole
Fluconazole is an antifungal with activity against most Candida species. Fluconazole is licensed and approved in Switzerland for prophylaxis of IC in patients with neutropenia induced by chemotherapy or radiotherapy at a daily dose of 200 to 400 mg once daily. Fluconazole (200 mg or 400 mg once daily) is still currently used as primary antifungal prophylaxis (standard of care) in all 7 centers participating in this trial. Fluconazole is available in Switzerland under the name of Diflucan® in capsules of 50 mg, 150 mg and 200 mg and in powder for preparation of suspension (50 mg/5 ml and 200 mg/5 ml (forte)) or perfusion (2 mg/1 ml). Several generics of Diflucan® are authorized in Switzerland. Prescribing Diflucan® or any of its generics will remain at the discretion of and based on the standard operating procedures (SOP) at each institution.
RECRUITING
University Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
RECRUITING
University Hospital of Geneva (HUG), Geneva
RECRUITING
Cantonal Hospital HFR, Fribourg
RECRUITING
University Hospital Leuven (UZ Leuven), Leuven
RECRUITING
University Hospital Basel, Basel
RECRUITING
Cantonal Hospital Aarau, Aarau
RECRUITING
AZ Sint-Jan Hospital, Bruges
RECRUITING
Ghent University Hospital, Ghent
RECRUITING
Henri Mondor Hospital, Créteil
Swiss National Science Foundation
OTHER
Bochud Pierre-Yves
OTHER