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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill patients | Patients admitted on ICU. |
| |
| Hematology patients | Patients admitted on the hematology ward. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection | Other | Plasma, urine, BAL and ascitic fluid sample collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma exposure and PK parameters | 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. | July 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Covariates | To document correlating covariates and to stimulate the pharmacokinetics of L-AmB to provide a rationale for optimal dosing strategy in critically ill patients. | July 2020 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Van Daele, PharmD | Contact | +3216343264 | ruth.vandaele@uzleuven.be | |
| Isabel Spriet, PharmD, PhD | Contact | +3216341261 | isabel.spriet@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Isabel Spriet, PharmD, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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Blood (plasma) Urine BAL (bronchoalveolar lavage) Ascitic fluid
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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