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The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine caspofungin concentrations in 20 ICU patients, who will get caspofungin as standard care.
Full PK curves will be taken on day 3 and a limited PK curve on day 7, trough levels will be taken daily.
The pharmacokinetics of caspofungin are expected to be different in ICU patients compared to non-ICU patients and healthy volunteers due to underlying disease(s). Therefore, extrapolation of data from healthy volunteers and non-ICU patients is not possible.
To be able to include 20 patients within the study duration, a multi-centre approach is necessary.
Patients will receive standard care, as stated in the SPC or according to local protocols. Blood sampling for PK analysis will be retrieved through a central venous catheter. Approximately 60mL will be drawn in total for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Although steady state of caspofungin will be achieved after approximately 14 days of treatment, full PK curves will be taken on day 3. As probably not all patients included will be treated with caspofungin for 14 days, taking full PK curves on day 14 is considered not feasible. These two moments of PK analysis will enable the determination steady state and enable the determination of intra-individual variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caspofungin | caspofungin dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caspofungin | Drug | normal dosage for caspofungin, not adapted for the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | AUC0-tau, AUC0-inf (Time Frame: predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose on Day 3 and predose, 1, 4, 8, 12 hours + 6 days after the dose on Day 7) of caspofungin | day 3 and day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| co-variates influencing PK of caspofungin | identify co-variates of influence on the pharmacokinetics of caspofungin | day 3 and day 7 |
| Number of Participants with Adverse Events | the adverse events will be recorded in IC patients during the study |
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Inclusion Criteria:
Exclusion Criteria:
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intensive care patients with invasive fungal infection
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| Name | Affiliation | Role |
|---|---|---|
| Roger Brüggemann, PhD, PharmD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Netherlands | ||||
| Canisius Wilhelmina Hospital (CWZ) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25139840 | Result | Muilwijk EW, Schouten JA, van Leeuwen HJ, van Zanten AR, de Lange DW, Colbers A, Verweij PE, Burger DM, Pickkers P, Bruggemann RJ. Pharmacokinetics of caspofungin in ICU patients. J Antimicrob Chemother. 2014 Dec;69(12):3294-9. doi: 10.1093/jac/dku313. Epub 2014 Aug 19. |
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Plasma samples for determination of caspofungin
| 14 days |
| Nijmegen |
| Netherlands |
| Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands |
| University Medical Centre Utrecht | Utrecht | Netherlands |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D002177 | Candidiasis |
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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