PTX3-targeted Antifungal Prophylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBochud Pierre-Yves
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
Patients with neutropenia (absolute neutrophils count<500 cells/mm3) upon presentation and prior to chemotherapy initiation.
Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3.
Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals
Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast-feeding.
Trial design
Treatments tested in this trial
- Posaconazole
- Fluconazole
Treatment groups
410 Participants
are divided into 2 treatment groupsSponsors and collaborators
Bochud Pierre-Yves
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov