The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.
Adult (≥18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care.
Able to give informed consent.
Unable to give informed consent.
Single group
Posaconazole pharmacokinetics
DrugBlood samples will be collected on Days 7, 14 and 21 from the onset of Posaconazole prophylactic treatment If significant diarrhoea occurs, additional blood samples will be collected twice weekly until symptoms resolve. All blood samples will be used for Posaconazole pharmacokinetics study.
Pre-dose plasma Posaconazole concentrations
The median interquartile range pre-dose plasma Posaconazole concentrations equal or greater than 0.7 mg/L will be assessed.
Clinical symptoms affecting plasma Posaconazole concentrations.
Observed association between concurrent patient factors with change in plasma Posaconazole concentrations.
The number/proportion of patients achieving desirable pre-dose plasma Posaconazole concentrations.
The number/proportion of patients achieving pre-dose plasma Posaconazole concentrations greater or equal to 0.7 mg/L will be assessed.
Effects of diarrhea on plasma Posaconazole concentration
Correlation between the presence/extent of diarrhea with change in plasma Posaconazole concentrations.
Alteration in prophylaxis due to Posaconazole-attributed toxicities.
Frequency of Posaconazole-attributed toxicities resulting in dose changes or cessation of prophylaxis will be noted.
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Melbourne Health
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
