Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID03717623

Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Oral Posaconazole Prophylaxis for Invasive Fungal Infection

Led by Melbourne Health · Updated on 2025-02-28

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Melbourne Health

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how the body processes Posaconazole, an oral antifungal medicine given as a preventive treatment to patients undergoing cancer therapies, including chemotherapy or stem cell transplants. This study focuses on patients receiving Posaconazole to prevent invasive fungal infections during their cancer treatment, aiming to better understand the medicine's behavior in these settings. Participants will take Posaconazole tablets, usually 300mg once daily, as part of their standard care. The treatment duration depends on individual hospital policies but generally starts before or with chemotherapy and continues until the patient's immune system recovers. In stem cell transplant patients, Posaconazole also begins around the transplant time and lasts about three months or longer if needed. Blood samples will be collected on days 7, 14, and 21 after starting Posaconazole, with extra samples taken if patients experience significant diarrhea or other absorption issues. If a patient switches to an intravenous form due to complications, a blood sample will be taken after the last oral dose. During the study, participants will provide blood samples and share clinical information while on Posaconazole and for up to seven days after stopping the drug for infection follow-up. Those diagnosed with fungal infections will be tracked for 30 days to monitor outcomes. Researchers will measure Posaconazole levels in the blood to assess how symptoms like diarrhea or conditions such as graft versus host disease affect the medicine's concentration. The study aims to ensure better dosing and management of Posaconazole in cancer patients at risk of fungal infections.

CONDITIONS

Brief Title

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (≥18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care.
  • Able to give informed consent.
Not Eligible

You will not qualify if you...

  • Unable to give informed consent.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of Posaconazole prophylaxis course according to local hospital policy, generally starting prior to or with chemotherapy or transplant and continuing up to approximately 3 months or longer depending on clinical condition.

Participants receive oral Posaconazole prophylaxis as part of their standard care during cancer treatment. Blood samples are collected on Days 7, 14, and 21 of prophylaxis to study Posaconazole levels. If significant diarrhea occurs, additional blood samples are collected twice weekly until symptoms resolve. Participants may switch to intravenous Posaconazole if needed due to malabsorption, infection, or toxicity.

Blood sample collection visits on Days 7, 14, and 21, plus additional visits twice weekly if diarrhea occurs

Follow-up

Duration - Up to 30 days after diagnosis of invasive fungal infection or 7 days after last Posaconazole dose for others

Participants are followed for clinical outcomes during the blood sample collection period and up to 7 days after stopping Posaconazole prophylaxis. Those diagnosed with invasive fungal infection are followed for 30 days post-diagnosis.

Follow-up visits as needed for clinical data collection during and after prophylaxis

Trial Site Locations

Total: 1 location

1

Melbourne Health

Parkville, Victoria, Australia, 3050

Actively Recruiting

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Research Team

M

Monica Slavin, Prof

T

Tseng Lau, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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