Pharmacokinetics and optimal dosage of caspofungin in critically ill patients with suspected invasive candidiasis.

Phase 4

Completed

• Conditions: Suspected invasive candidiasis; suspected invasive fungal infection; 10017528

• Registration Number: NL-OMON40105
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Treatment with caspofungin.
Admission to an ICU.
Age >= 18 years.
Suspected invasive candidiasis.

Exclusion Criteria

Blood sampling by central venous catheter or peripheral cannula not possible.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the optimal dosage of caspofungin in relation to<br /><br>adequate exposure in critically ill patients. The AUC of caspofungin is used as<br /><br>a measure for the exposure. The optimal dosage can be given as a starting<br /><br>dosage for empirical treatment with caspofungin in critically ill patients.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Pharmacokinetic parameters of caspofungin in critically ill patients.<br /><br>2) Correlation of pharmacokinetic parameters and the plasma concentration of<br /><br>caspofungin with disease severity scores.<br /><br>3) Correlation of the plasma concentration of caspofungin with candida<br /><br>eradication.<br /><br>4) Correlation of the plasma concentration of caspofungin with inflammation<br /><br>parameters.<br /><br>5) AUC/MIC ratio and Cmax/MIC ratio.<br /><br>6) Constructing a pharmacokinetic model of caspofungin in critically ill<br /><br>patients.<br /><br>7) Drug-related adverse events of caspofungin.<br /><br>8) The amount of caspofungin that is lost in dialysis.</p><br>