Critically Ill | Optimal Dosage of Caspofungin in Critically Ill Patients
Critically Ill research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Suspected Invasive Candidiasis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Caspofungin1 arm, dose adjustment of caspofungin when exposure is inadequate
Start Date: November 2013
Completed Date: October 2015
Phase: Phase 4
Primary Outcome: The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
Secondary Outcome: Pharmacokinetic parameters of caspofungin in critically ill patients.
Study sponsors, principal investigator, and references
Principal Investigator: Jan-Willem Alffenaar, PharmD, PhD
Lead Sponsor: University Medical Center Groningen