PTX3-targeted Antifungal Prophylaxis

NARecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

February 11, 2019

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
CandidiasisFungal InfectionAcute Myeloid LeukemiaGenetic PredispositionAspergillosis
Interventions
DRUG

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.

DRUG

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.

Trial Locations (9)

1011

RECRUITING

University Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

1211

RECRUITING

University Hospital of Geneva (HUG), Geneva

1708

RECRUITING

Cantonal Hospital HFR, Fribourg

3000

RECRUITING

University Hospital Leuven (UZ Leuven), Leuven

4031

RECRUITING

University Hospital Basel, Basel

5001

RECRUITING

Cantonal Hospital Aarau, Aarau

8000

RECRUITING

AZ Sint-Jan Hospital, Bruges

9000

RECRUITING

Ghent University Hospital, Ghent

94010

RECRUITING

Henri Mondor Hospital, Créteil

All Listed Sponsors
collaborator

Swiss National Science Foundation

OTHER

lead

Bochud Pierre-Yves

OTHER