Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections (PIRAÑA)
Allogeneic Stem Cell Transplant, Acute Graft Versus Host Disease, Acute Myeloid Leucaemia
About this trial
This is an interventional prevention trial for Allogeneic Stem Cell Transplant
Eligibility Criteria
Inclusion Criteria:
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
- Subject is at least 18 years of age on the day of providing informed consent.
- Patient receives immunosuppressive therapy for acute or chronic GVHD grade II-IV, reduced intensity conditioning regimens for allogeneic stem cell transplant, or first remission induction chemotherapy for AML/MDS.
- In case of acute GVHD grade II-IV, patient has received less than 1 week of immunosuppressive therapy.
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- Has an ALAT <200U/L, ALAT <225U/L, alkaline phosphatase <60 U/L and a bilirubin level <50 μmol/L.
- Subject is capable of receiving oral tablets.
- Subject is managed with a central venous or arterial catheter.
Exclusion Criteria:
- Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation.
- Relevant history or presence of cardiovascular disorders (specifically QTc-time prolongation).
- Inability to understand the nature of the trial and the procedures required
- Any signs or symptoms of invasive fungal disease or the use of antifungal drugs within the previous month.
- Has previously participated in this trial.
Sites / Locations
- Universitaire Ziekenhuizen Leuven
- Radboudumc
Arms of the Study
Arm 1
Arm 2
Other
Other
intravenous followed by oral
oral followed by intravenous
Start with posaconazole IV 300mg BID on the first day. Posaconazole will be infused over a period of 90 minutes. Days 2-7 patients will receive posaconazole IV 300mg QD. Days 8-12 patients will receive posaconazole PO 300mg QD. Days 13-16 patients will receive posaconazole PO 200mg QD. 3 PK curves will be determined on days 7, 12 and 16 (after the 7th, 12th and 16th dosage).
Start with posaconazole PO 300mg BID on the first day. Days 2-7: patients will receive posaconazole PO 300mg QD. Days 8-12: patients will receive posaconazole IV 300mg QD. Posaconazole will be infused over a period of 90 minutes. Days 13-16 patients will receive posaconazole IV 200mg QD. 3 PK curves will be determined on days 7, 12 and 16 (after the 7th, 12th and 16th dosage).