Investigating how Posaconazole works in cancer patients receiving chemotherapy or stem cell transplants
Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Treatment With Oral Posaconazole Prophylaxis for Invasive Fungal Infection
This study is testing how well the antifungal drug Posaconazole works in adults getting chemotherapy or stem cell transplants to see if it can help prevent serious fungal infections.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Melbourne Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Parkville, Victoria) |
| Trial ID | NCT03717623 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the pharmacokinetics of Posaconazole, an antifungal medication, in adult patients undergoing chemotherapy or stem cell transplants. Participants will receive oral Posaconazole as a standard prophylactic treatment against invasive fungal infections and will provide blood samples at specified intervals to monitor drug levels. The study will help determine how well the drug is absorbed and metabolized in this patient population, particularly in those who may experience complications such as malabsorption. The findings could inform dosing strategies and improve patient outcomes during cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adult hematology patients aged 18 and older who are receiving Posaconazole prophylaxis in an inpatient setting.
Not a fit: Patients who are unable to give informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of antifungal prophylaxis in vulnerable cancer patients, potentially reducing the incidence of serious infections.
How similar studies have performed: Other studies have shown promising results in understanding the pharmacokinetics of antifungal agents in similar patient populations, suggesting that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Parkville, Victoria
- Melbourne Health — Parkville, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Monica Slavin, Prof
- Email: monica.slavin@mh.org.au
- Phone: 61 3 9342 9403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.