Optimal Dosage of Caspofungin in Critically Ill Patients

Pharmacokinetics and Optimal Dosage of Caspofungin in Critically Ill Patients With Suspected Invasive Candidiasis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01994096

Enrollment

Registered

2013-11-25

Start date

2013-11-30

Completion date

2015-10-31

Last updated

2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Suspected Invasive Candidiasis

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.

Interventions

DRUGCaspofungin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients.	7 days

Secondary

Measure	Time frame
Pharmacokinetic parameters of caspofungin in critically ill patients.	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
Correlation of pharmacokinetic parameters and the plasma concentration of caspofungin with disease severity scores.	3 days
Constructing a pharmacokinetic model of caspofungin in critically ill patients.	28 days
Drug-related adverse events of caspofungin.	28 days
AUC/MIC ratio and highest observed plasma concentration (Cmax)/MIC ratio.	7 days

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026