Testing posaconazole or fluconazole to prevent fungal infections in leukemia
Compares antifungal drugs to prevent fungal infection in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: PTX3-targeted Antifungal Prophylaxis
Key facts
- Where
- Gent and Leuven, BelgiumSee the 3 sites
- Phase
- Phase 4
Where in Belgium
- AZ Sint-Jan Brugge-Oostende AVBelgiumTaking people
- UZ GentGent, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bochud Pierre-Yves
- Trial code
- NCT03828773EU 2024-517211-79-00
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
PTX3 Genetically Stratified Randomized Double-blinded Allocation Event-driven Clinical Trial for Antifungal Prophylaxis in Patients With Acute Myeloid Leukemia
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.
Inclusion: Signed Informed Consent according to national/local regulations; Age ≥18 years; Diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome in transformation (MDSit) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage remission chemotherapy; Planned hospital admission for the duration of the neutropenic phase (absolute neutrophils count <500 cells/mm3).
Exclusion: Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast-feeding; Diagnosis and treatment for an Invasive Fungal Infection (IFI) within 3 months prior to study enrolment and an Invasive Mold Infection (IMI) at any point prior to or at the time of enrolment; Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol; Receipt of a prior allogeneic Hematopoietic Cell Transplantation (HCT); Previous exposure to mold-active prophylaxis (>48 hours within 7 days of inclusion); Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals; Patients with neutropenia (absolute neutrophils count<500 cells/mm3) upon presentation and prior to chemotherapy initiation; Severe liver dysfunction, defined as at least one of the following markers: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or alkaline phosphatase above >5x upper limit of normality: and/or total bilirubin above >3x upper limit of normality; Patients with an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women; Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine (because of the possibility of QT prolongation), sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (e.g., ergotamine, dihydroergotamine); Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3; Patients with relapsed leukemia already included in the trial; Patient not affiliated to the French social security system; Patient under legal protection (guardianship, curatorship).