Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates (CASCADE)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates|
- Area Under Curve (AUC) [ Time Frame: day 3 and day 7 ] [ Designated as safety issue: No ]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
- co-variates influencing PK of caspofungin [ Time Frame: day 3 and day 7 ] [ Designated as safety issue: No ]identify co-variates of influence on the pharmacokinetics of caspofungin
- Number of Participants with Adverse Events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]the adverse events will be recorded in IC patients during the study
Biospecimen Retention: Samples Without DNA
Plasma samples for determination of caspofungin
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
normal dosage for caspofungin, not adapted for the study
Other Name: Cancidas
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.
|Contact: Roger Brüggemann, PhD, PharmDfirstname.lastname@example.org|
|Contact: Eline Muilwijk, PharmD, MScemail@example.com|
|Contact: Henk van Leeuwen, MD|
|Principal Investigator: Henk van Leeuwen, MD|
|Radboud University Nijmegen Medical Centre||Recruiting|
|Contact: Peter Pickkers, MD, PhD +31243611111|
|Sub-Investigator: Peter Pickkers, MD, PhD|
|Canisius Wilhelmina Hospital (CWZ)||Recruiting|
|Contact: Jeroen Schouten, MD, PhD +31243657657|
|Principal Investigator: Jeroen Schouten, MD, PhD|
|University Medical Centre Utrecht||Recruiting|
|Contact: Dylan de Lange, MD, PhD +3188 75 555 55|
|Principal Investigator: Dylan de Lange, MD, PhD|
|Principal Investigator:||Roger Brüggemann, PhD, PharmD||Radboud University|