Optimal Dosage of Caspofungin in Critically Ill Patients

Phase 4

Completed

• Conditions: Suspected Invasive Candidiasis; Critically Ill
• Interventions: Drug: Caspofungin

• Registration Number: NCT01994096
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caspofungin	Caspofungin	1 arm, dose adjustment of caspofungin when exposure is inadequate

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands