Critically Ill Patients, Liposomal Amphotericin B, Pharmacokinetics
Conditions
Brief summary
This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.
Detailed description
This phase IV, open label, non-randomized, monocenter pharmacokinetic study will be carried out in critically ill and non-critically ill (hematology) patients receiving multiple dose treatment with L-AmB. The pharmacokinetic exposure to liposomal amphotericin B in plasma, urine, BAL and ascitic fluid will be compared between the two population groups in an early and late exposure day. Correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.
Interventions
OTHERSample collection
Plasma, urine, BAL and ascitic fluid sample collection.
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma exposure and PK parameters | July 2020 | To document and compare plasma exposure and PK parameters in an ICU vs. non ICU hematology patient cohort in the early and late phase of L-AmB treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Covariates | July 2020 | To document correlating covariates and to stimulate the pharmacokinetics of L-AmB to provide a rationale for optimal dosing strategy in critically ill patients. |
Countries
Belgium
Contacts
Primary ContactRuth Van Daele, PharmD
Backup ContactIsabel Spriet, PharmD, PhD
Outcome results
None listed