Pharmacokinetics Clinical Trial
— POPULAROfficial title:
Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Treatment With Oral Posaconazole Prophylaxis for Invasive Fungal Infection
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (=18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care. - Able to give informed consent. Exclusion Criteria: - Unable to give informed consent. |
Country | Name | City | State |
---|---|---|---|
Australia | Melbourne Health | Parkville | Victoria |
Lead Sponsor | Collaborator |
---|---|
Melbourne Health | Merck Sharp & Dohme LLC |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs. | |
Secondary | Clinical symptoms affecting plasma Posaconazole concentrations. | Observed association between concurrent patient factors with change in plasma Posaconazole concentrations. | At Screening, Days 7, 14 and 21, and 72 hours after onset of diarrhoea, and when invasive fungal infection occurs. | |
Secondary | 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. | On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs. | |
Secondary | Effects of diarrhea on plasma Posaconazole concentration | Correlation between the presence/extent of diarrhea with change in plasma Posaconazole concentrations. | When diarrhea occurs during Posaconazole prophylaxis on Days 1 to 21. | |
Secondary | Alteration in prophylaxis due to Posaconazole-attributed toxicities. | Frequency of Posaconazole-attributed toxicities resulting in dose changes or cessation of prophylaxis will be noted. | When change in or cessation of oral Posaconazole prophylaxis occurs during Day 1 to Day 21. |
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