Pharmacokinetics of Micafungin in Critically Ill Patients

Completed

• Conditions: Critical Illness; Invasive Candidiasis

• Registration Number: NCT01716988
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-30
• Primary Completion: 2016-12
• Status Verified: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Treatment with micafungin.
• Admission to an ICU.
• Age ≥ 18 years.
• Invasive candidiasis.

Exclusion Criteria

• Blood sampling not possible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.	4 days	Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands