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Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

PHASE4RECRUITING

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.

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Study details:

Participants receiving Posaconazole prophylaxis for invasive fungal infection while undergoing cancer treatment will be required to sign an informed consent and donate blood samples for the study. Posaconazole is routinely administered as a prophylaxis using the oral tablet formulation (300mg once daily) as a standard care. Each prophylaxis course-duration will be defined according to local policy at each hospital.

In general, Posaconazole prophylaxis commences prior to or with induction or consolidation chemotherapy in AML/MDS patients and continues until neutrophil recovery. In allo-HSCT setting, Posaconazole prophylaxis routinely commences on the day of transplant or with conditioning chemotherapy and continues for approximately 3 months after transplant, except in patients with initiation of intensive immunosuppression after diagnosis of acute or chronic GVHD, administration will go for at least 16 weeks or until prednisolone dose is less than 10mg per day, whichever is later. If patients are suspected or have proven malabsorption or are required to switch to an alternative antifungal agent such as in the case of suspected invasive fungal infection or Posaconazole toxicity, a switch to intravenous formulation of Posaconazole will take place.

Blood 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, with the first sample being taken 3 days after the onset of diarrhoea. If gastrointestinal absorption is considered inadequate or invasive fungal infection is suspected and patients are switched either to IV antifungal prophylaxis or antifungal treatment as part of their standard care, a blood sample will be collected 20-24 hours after the last oral Posaconazole dose.

Study participants will be followed up with respect to clinical data collection during the blood sample collection period and for up to 7 days after the last dose of Posaconazole for invasive fungal infection follow-up, and for the entire antifungal prescribing period (prophylaxis and/or treatment). Participants with diagnosed invasive fungal infection will be followed up to 30-days post-diagnosis with respect to clinical outcomes.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2019-08-01

    Primary completion: 2023-12-30

    Study completion finish: 2023-12-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE4

    trial

    Trial ID

    NCT03717623

    Intervention or treatment

    DRUG: Posaconazole pharmacokinetics

    Conditions

    • Fungal Infection
    • Posaconazole
    • Pharmacokinetics
    • Invasive Candidiases
    • Invasive Aspergillosis
    • Invasive Mycosis
    • Prophylaxis

    Find a site

    Closest Location:

    Melbourne Health

    Research sites nearby

    Select from list below to view details:

    • Melbourne Health

      Parkville, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Posaconazole prophylaxis
    • Blood samples will be taken from participants undergoing cancer treatment and receiving Posaconazole prophylaxis. The samples will be used for Posaconazole pharmacokinetics study.
    DRUG: Posaconazole pharmacokinetics
    • Blood 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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Pre-dose plasma Posaconazole concentrationsThe 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 outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    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.
    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.
    Effects of diarrhea on plasma Posaconazole concentrationCorrelation between the presence/extent of diarrhea with change in plasma Posaconazole concentrations.When diarrhea occurs during Posaconazole prophylaxis on Days 1 to 21.
    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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    References

    Clinical Trials Gov: Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

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