Optimal Dosage of Caspofungin in Critically Ill Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Critically Ill, Suspected Invasive Candidiasis

Intervention / Treatment
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* Drug: Caspofungin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caspofungin<br>1 arm, dose adjustment of caspofungin when exposure is inadequate | Drug: Caspofungin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The optimal dosage of caspofungin in relation to adequate exposure (measured as AUC) in critically ill patients. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |