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)
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|ClinicalTrials.gov Identifier: NCT01533558|
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : August 29, 2013
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.
|Condition or disease||Intervention/treatment|
|Invasive Fungal Infection||Drug: caspofungin|
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|
|Actual Enrollment :||20 participants|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2013|
normal dosage for caspofungin, not adapted for the study
Other Name: Cancidas
- Area Under Curve (AUC) [ Time Frame: day 3 and day 7 ]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 ]identify co-variates of influence on the pharmacokinetics of caspofungin
- Number of Participants with Adverse Events [ Time Frame: 14 days ]the adverse events will be recorded in IC patients during the study
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533558
|Canisius Wilhelmina Hospital (CWZ)|
|Radboud University Nijmegen Medical Centre|
|University Medical Centre Utrecht|
|Principal Investigator:||Roger Brüggemann, PhD, PharmD||Radboud University|