| NCT ID | NCT03828773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bochud Pierre-Yves |
| Condition | Candidiasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 410 participants |
| Start Date | 2019-02-11 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 410 participants in total. It began in 2019-02-11 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: 1. Signed Informed Consent according to national/local regulations. 2. Age ≥18 years. 3. Diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome in transformation (MDSit) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage remission chemotherapy. 4. Planned hospital admission for the duration of the neutropenic phase (absolute neutrophils count \<500 cells/mm3). Exclusion Criteria: 1. Patients with neutropenia (absolute neutrophils count\<500 cells/mm3) upon presentation and prior to chemotherapy initiation. 2. Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3. 3. Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals 4. Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast-feeding. 5. 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. 6. 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. 7. Patients with an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women. 8. 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). 9. Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol. 10. Receipt of a prior allogeneic Hematopoietic Cell Transplantation (HCT). 11. Previous exposure to mold-active prophylaxis (\>48 hours within 7 days of inclusion). 12. Patients with relapsed leukemia already included in the trial. 13. Patient not affiliated to the French social security system 14. Patient under legal protection (guardianship, curatorship)
Contact & Investigator
Pierre-Yves Bochud, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire Vaudois
Frequently Asked Questions
Who can join the NCT03828773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Candidiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03828773 currently recruiting?
Yes, NCT03828773 is actively recruiting participants. Contact the research team at Pierre-Yves.Bochud@chuv.ch for enrollment information.
Where is the NCT03828773 trial being conducted?
This trial is being conducted at Ghent, Belgium, Bruges, Belgium, Leuven, Belgium, Créteil, France and 5 additional locations.
Who is sponsoring the NCT03828773 clinical trial?
NCT03828773 is sponsored by Bochud Pierre-Yves. The principal investigator is Pierre-Yves Bochud, MD at Centre Hospitalier Universitaire Vaudois. The trial plans to enroll 410 participants.