Clinical trial NCT01994096: Optimal Dosage of Caspofungin in Critically Ill Patients
Official title: Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critically Ill
Suspected Invasive Candidiasis
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight \> 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score.

As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.


Eligibility criteria: Inclusion Criteria:

* Treatment with caspofungin.
* Admission to an ICU.
* Age ≥ 18 years.
* Suspected invasive candidiasis, established by the physician.

Exclusion Criteria:

* Blood sampling by central venous catheter or peripheral cannula not possible.

Primary outcomes:
measure: The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacokinetic parameters of caspofungin in critically ill patients.
timeFrame: 3 days
measure: Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.
timeFrame: 3 days
measure: Correlation of the plasma concentration of caspofungin with candida eradication.
timeFrame: 28 days
measure: Correlation of the plasma concentration of caspofungin with inflammation parameters.
timeFrame: 3 days
measure: AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.
timeFrame: 7 days
measure: Constructing a pharmacokinetic model of caspofungin in critically ill patients.
timeFrame: 28 days
measure: Drug-related adverse events of caspofungin.
timeFrame: 28 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jan-Willem Alffenaar, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Elst KC, Veringa A, Zijlstra JG, Beishuizen A, Klont R, Brummelhuis-Visser P, Uges DR, Touw DJ, Kosterink JG, van der Werf TS, Alffenaar JC. Low Caspofungin Exposure in Patients in Intensive Care Units. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01582-16. doi: 10.1128/AAC.01582-16. Print 2017 Feb.