Pharmacokinetics of Micafungin in Critically Ill Patients

January 11, 2017 updated by: Jan-Willem C Alffenaar, University Medical Center Groningen

Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with invasive candidiasis admitted to an intensive care unit.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Blood sampling not possible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Micafungin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
Time Frame: 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.
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters of micafungin in ICU patients.
Time Frame: 4 days
Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
4 days
Time (in days) to culture conversion.
Time Frame: max 28 days
Number of days untill cultures are negative.
max 28 days
Correlation of the plasma concentration of micafungin with response to treatment.
Time Frame: max 28 days
Correlation of the level of micafungin concentration with outcome.
max 28 days
Correlation of the plasma concentration of micafungin with inflammation parameters.
Time Frame: 4 days
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.
Time Frame: max 28 days
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.
Time Frame: max 28 days
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.
Time Frame: 28 days
Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL39246.042.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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