Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections

• Status: Completed
• Trial end date: 2019-09-07
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non-myeloablative (NMA)) for allogeneic Stem Cell Transplant (SCT), remission induction chemotherapy for acute myeloid leukemia (AML) or myelo dysplastic syndrome (MDS) or being treated for severe graft versus host disease (GvHD) and determines the impact of mucositis on the pharmacokinetics of posaconazole new solid oral.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Universitaire Ziekenhuizen Leuven
• Treatments: Posaconazole

Criteria

Inclusion Criteria:

1. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

2. Subject is at least 18 years of age on the day of providing informed consent.

3. 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.

4. In case of acute GVHD grade II-IV, patient has received less than 1 week of immunosuppressive therapy.

5. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.

6. Has an ALAT <200U/L, ALAT <225U/L, alkaline phosphatase <60 U/L and a bilirubin level <50 μmol/L.

7. Subject is capable of receiving oral tablets.

8. Subject is managed with a central venous or arterial catheter.

Exclusion Criteria:

1. Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation.

2. Relevant history or presence of cardiovascular disorders (specifically QTc-time prolongation).

3. Inability to understand the nature of the trial and the procedures required

4. Any signs or symptoms of invasive fungal disease or the use of antifungal drugs within the previous month.

5. Has previously participated in this trial.