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.
Study Type
OBSERVATIONAL
Enrollment
19
University Medical Center Groningen
Groningen, Netherlands
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.
Time frame: 4 days
Pharmacokinetic parameters of micafungin in ICU patients.
Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
Time frame: 4 days
Time (in days) to culture conversion.
Number of days untill cultures are negative.
Time frame: max 28 days
Correlation of the plasma concentration of micafungin with response to treatment.
Correlation of the level of micafungin concentration with outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 28 days
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