Actively Recruiting
PTX3-targeted Antifungal Prophylaxis
Led by Bochud Pierre-Yves · Updated on 2025-12-09
410
Participants Needed
9
Research Sites
459 weeks
Total Duration
On this page
Sponsors
B
Bochud Pierre-Yves
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.
CONDITIONS
Official Title
PTX3-targeted Antifungal Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent according to national/local regulations
- Age 18 years or older
- Diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome in transformation (MDSit) receiving intensive chemotherapy including induction, consolidation, or salvage remission chemotherapy
- Planned hospital admission for the duration of neutropenia with absolute neutrophil count below 500 cells/mm3
You will not qualify if you...
- Neutropenia (absolute neutrophil count below 500 cells/mm3) before starting chemotherapy
- Diagnosis of acute promyelocytic leukemia (APL) or AML-M3
- Known allergy, hypersensitivity, or serious reaction to azole antifungal drugs
- Pregnant or breastfeeding women
- Diagnosis and treatment for invasive fungal infection within 3 months before enrollment or invasive mold infection at or before enrollment
- Severe liver dysfunction with specific elevated liver enzyme or bilirubin levels
- Prolonged QTc interval on ECG (greater than 450 msec for men, greater than 470 msec for women)
- Use of contraindicated medications that cannot be stopped 24 hours before randomization
- Serious uncontrolled illness or comorbidity that may affect study adherence
- Previous allogeneic hematopoietic cell transplantation
- Prior exposure to mold-active prophylaxis over 48 hours within 7 days before inclusion
- Relapsed leukemia already included in the trial
- Not affiliated with the French social security system
- Under legal protection such as guardianship or curatorship
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Ghent University Hospital
Ghent, Belgium, Belgium, 9000
Terminated
2
AZ Sint-Jan Hospital
Bruges, Belgium, 8000
Actively Recruiting
3
University Hospital Leuven (UZ Leuven)
Leuven, Belgium, 3000
Actively Recruiting
4
Henri Mondor Hospital
Créteil, Île-de-France Region, France, 94010
Actively Recruiting
5
Cantonal Hospital Aarau
Aarau, Aarau, Switzerland, 5001
Actively Recruiting
6
University Hospital Basel
Basel, Basel, Switzerland, 4031
Actively Recruiting
7
Cantonal Hospital HFR
Fribourg, Canton of Fribourg, Switzerland, 1708
Actively Recruiting
8
University Hospital of Geneva (HUG)
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
9
University Hospital of Lausanne / Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
P
Pierre-Yves Bochud, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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