Clinical trial 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infection
Keywords: caspofungin
pharmacokinetics
invasive fungal infection
candidiasis
aspergillosis
intensive care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: intensive care patients with invasive fungal infection

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patient is admitted to an ICU
* Subject is at least 18 and not older than 65 years of age on the day of the first dosing
* Subject has been treated with caspofungin for a maximum of two days before enrolment in this trial
* Is managed with a central venous catheter

Exclusion Criteria:

* Is known to be hypersensitive to echinocandin antifungal agents
* Documented history of sensitivity to medicinal products or excipients similar to those found in the caspofungin preparation
* Positive HIV test or hepatitis B or C test
* History of QT time prolongation
* History of or current abuse of drugs, alcohol or solvents
* Has previously participated in this trial

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: day 3 and day 7
Secondary outcomes:
measure: co-variates influencing PK of caspofungin
timeFrame: day 3 and day 7
measure: Number of Participants with Adverse Events
timeFrame: 14 days
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital (CWZ)
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: Radboud University Medical Center
name: Roger Brüggemann, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.