Status:
RECRUITING
PTX3-targeted Antifungal Prophylaxis
Lead Sponsor:
Bochud Pierre-Yves
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Candidiasis
Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Detailed Description
Background: Invasive mold infections (IMI, grouping infections due to Aspergillus spp \[IA\] and non-Aspergillus mold) are a major concern in hematological patients, such as those with acute myeloid ...
Eligibility Criteria
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
- 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.
- 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.
- 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).
- 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 relapsed leukemia already included in the trial.
- Patient not affiliated to the French social security system
- Patient under legal protection (guardianship, curatorship)
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT03828773
Start Date
February 11 2019
End Date
November 30 2027
Last Update
December 9 2025
Active Locations (9)
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1
Ghent University Hospital
Ghent, Belgium, Belgium, 9000
2
AZ Sint-Jan Hospital
Bruges, Belgium, 8000
3
University Hospital Leuven (UZ Leuven)
Leuven, Belgium, 3000
4
Henri Mondor Hospital
Créteil, Île-de-France Region, France, 94010