Optimal Dosage of Caspofungin in Critically Ill Patients
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Critically Ill; Suspected Invasive Candidiasis
Intervention: Caspofungin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s):
Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator, Affiliation: University Medical Center Groningen
Overall contact:
Jan-Willem Alffenaar, PharmD, PhD, Phone: 0031503614070, Email: j.w.c.alffenaar@umcg.nl
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.
Clinical Details
Official title: Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores. Correlation of the plasma concentration of caspofungin with candida eradication. Correlation of the plasma concentration of caspofungin with inflammation parameters. AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio. Constructing a pharmacokinetic model of caspofungin in critically ill patients. Drug-related adverse events of caspofungin.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Jan-Willem Alffenaar, PharmD, PhD, Phone: 0031503614070, Email: j.w.c.alffenaar@umcg.nl
University Medical Centre Groningen, Groningen 9700 RB, Netherlands; Recruiting
Jan-Willem Alffenaar, PharmD, PhD, Phone: 0031503614070, Email: j.w.c.alffenaar@umcg.nl
Jan-Willem Alffenaar, PharmD, PhD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: June 17, 2015
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