Clinical Trial: Pharmacokinetics of Micafungin in Critically Ill Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

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 Summary:
Sponsor: University Medical Center Groningen

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University Medical Center Groningen

Dates:
Date Received: October 8, 2012
Date Started: October 2012
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017