Comparing how liposomal amphotericin B works in critically ill and non-critically ill hematology patients
Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates
This study is trying to see how the antifungal drug liposomal amphotericin B works in critically ill versus non-critically ill patients with blood disorders to find better ways to dose it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT03529617 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the pharmacokinetics of liposomal amphotericin B (L-AmB) in critically ill patients versus non-critically ill hematology patients. It will involve collecting samples from both groups to analyze the drug's exposure in plasma, urine, bronchoalveolar lavage (BAL), and ascitic fluid at different time points. The study seeks to identify covariates that may influence optimal dosing strategies for critically ill patients receiving L-AmB. By understanding these differences, the study hopes to improve treatment protocols for this patient population.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients and non-critically ill hematology patients who are being treated with liposomal amphotericin B.
Not a fit: Patients who are DNR 2 or 3, pregnant or lactating, or have a documented intolerance to liposomal amphotericin B may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for critically ill patients receiving liposomal amphotericin B.
How similar studies have performed: While this study explores a specific pharmacokinetic comparison, similar studies have shown varying success in optimizing drug dosing in critically ill populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Treatment with L-AmB * Admitted to an ICU or Hematology ward Exclusion Criteria: * DNR 2 or 3 * Pregnant or lactating women * Previous documentation of intolerance/sensitivity to L-AmB
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Isabel Spriet, PharmD, PhD — UZ Leuven
- Study coordinator: Ruth Van Daele, PharmD
- Email: ruth.vandaele@uzleuven.be
- Phone: +3216343264
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.