NCT01533558

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Invasive Fungal Infection

Interventions

Type	Name	Description
DRUG	caspofungin	normal dosage for caspofungin, not adapted for the study

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2012-02-15
• Last updated: 2020-12-01

Locations

4 sites across 1 country: Netherlands