Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis
Overview
- Phase
- Phase 4
- Intervention
- Caspofungin
- Conditions
- Critically Ill
- Sponsor
- University Medical Center Groningen
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
JWC Alffenaar
PharmD, PhD
University Medical Center Groningen
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.
Arms & Interventions
Caspofungin
1 arm, dose adjustment of caspofungin when exposure is inadequate
Intervention: Caspofungin
Outcomes
Primary Outcomes
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.
Time Frame: 7 days
Secondary Outcomes
- Pharmacokinetic parameters of caspofungin in critically ill patients.(3 days)
- Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.(3 days)
- Correlation of the plasma concentration of caspofungin with candida eradication.(28 days)
- Correlation of the plasma concentration of caspofungin with inflammation parameters.(3 days)
- AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.(7 days)
- Constructing a pharmacokinetic model of caspofungin in critically ill patients.(28 days)
- Drug-related adverse events of caspofungin.(28 days)