Pharmacokinetics of Micafungin in Critically Ill Patients

This study is currently recruiting participants.
Verified November 2013 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
JWC Alffenaar, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01716988
First received: October 8, 2012
Last updated: November 12, 2013
Last verified: November 2013
  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 University Medical Centre Groningen:

Primary Outcome Measures:
  • Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.

  • Time (in days) to culture conversion. [ Time Frame: max 28 days ] [ Designated as safety issue: No ]
    Number of days untill cultures are negative.

  • Correlation of the plasma concentration of micafungin with response to treatment. [ Time Frame: max 28 days ] [ Designated as safety issue: No ]
    Correlation of the level of micafungin concentration with outcome.

  • Correlation of the plasma concentration of micafungin with inflammation parameters. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Micafungin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716988

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: J WC Alffenaar, PharmD, PhD    0031503614070    j.w.c.alffenaar@umcg.nl   
Principal Investigator: J WC Alffenaar, PharmD, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: JWC Alffenaar, PharmD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01716988     History of Changes
Other Study ID Numbers: NL39246.042.12
Study First Received: October 8, 2012
Last Updated: November 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
Micafungin
pharmacokinetics
invasive candidiasis
intensive care

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Critical Illness
Mycoses
Disease Attributes
Pathologic Processes
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014