Pharmacokinetics of Micafungin in Critically Ill Patients

Study Overview
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Brief Summary
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A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. 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. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied. The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.

Official Title
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Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

Conditions
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Critical Illness, Invasive Candidiasis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment with micafungin. Admission to an ICU. Age ≥ 18 years. Invasive candidiasis. Exclusion Criteria: Blood sampling 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Micafungin<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity. | Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of micafungin in ICU patients. | Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin. | 4 days | 
| Time (in days) to culture conversion. | Number of days untill cultures are negative. | max 28 days | 
| Correlation of the plasma concentration of micafungin with response to treatment. | Correlation of the level of micafungin concentration with outcome. | max 28 days | 
| Correlation of the plasma concentration of micafungin with inflammation parameters. | Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin. | 4 days | 
| Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio. | Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species. | max 28 days | 
| Composing a pharmacokinetic model of micafungin in critically ill patients. | Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples. | max 28 days | 
| Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio. | Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micafungin, pharmacokinetics, invasive candidiasis, intensive care