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.
Study Type
OBSERVATIONAL
Enrollment
20
normal dosage for caspofungin, not adapted for the study
Rijnstate Hospital
Arnhem, Netherlands
Canisius Wilhelmina Hospital (CWZ)
Nijmegen, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
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
Time frame: day 3 and day 7
co-variates influencing PK of caspofungin
identify co-variates of influence on the pharmacokinetics of caspofungin
Time frame: day 3 and day 7
Number of Participants with Adverse Events
the adverse events will be recorded in IC patients during the study
Time frame: 14 days
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