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Pharmacokinetics of Micafungin in Critically Ill Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716988
First Posted: October 30, 2012
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan-Willem C Alffenaar, University Medical Center Groningen
  Purpose

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.


Condition
Critical Illness Invasive Candidiasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

Resource links provided by NLM:


Further study details as provided by Jan-Willem C Alffenaar, University Medical Center Groningen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Pharmacokinetic parameters of micafungin in ICU patients. [ Time Frame: 4 days ]
    Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.

  • Time (in days) to culture conversion. [ Time Frame: max 28 days ]
    Number of days untill cultures are negative.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 19
Study Start Date: October 2012
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Micafungin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with invasive candidiasis admitted to an intensive care unit.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Blood sampling not possible.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716988


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
  More Information

Responsible Party: Jan-Willem C Alffenaar, PharmD, PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01716988     History of Changes
Other Study ID Numbers: NL39246.042.12
First Submitted: October 8, 2012
First Posted: October 30, 2012
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Jan-Willem C Alffenaar, University Medical Center Groningen:
Micafungin
pharmacokinetics
invasive candidiasis
intensive care

Additional relevant MeSH terms:
Critical Illness
Candidiasis
Candidiasis, Invasive
Disease Attributes
Pathologic Processes
Mycoses
Invasive Fungal Infections
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents