Pharmacokinetics of Micafungin in Critically Ill Patients

Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01716988

Enrollment

Registered

2012-10-30

Start date

2012-10-31

Completion date

2017-01-31

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Invasive Candidiasis

Keywords

Micafungin, pharmacokinetics, invasive candidiasis, intensive care

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Blood sampling not possible.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
Pharmacokinetic parameters of micafungin in ICU patients.	4 days	Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
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.
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.

Countries

Netherlands

Outcome results