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Pharmacokinetics of Micafungin in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01716988
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Jan-Willem C Alffenaar, University Medical Center Groningen

October 8, 2012
October 30, 2012
January 12, 2017
October 2012
December 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01716988 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Pharmacokinetics of Micafungin in Critically Ill Patients
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Probability Sample
Adult patients with invasive candidiasis admitted to an intensive care unit.
  • Critical Illness
  • Invasive Candidiasis
Not Provided
Micafungin
Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Brüggemann RJ, Koster RA, Kampinga GA, Kosterink JG, van der Werf TS, Zijlstra JG, Touw DJ, Alffenaar JWC. Pharmacokinetic Properties of Micafungin in Critically Ill Patients Diagnosed with Invasive Candidiasis. Antimicrob Agents Chemother. 2017 Nov 22;61(12). pii: e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
20
January 2017
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Blood sampling not possible.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01716988
NL39246.042.12
No
Not Provided
Not Provided
Jan-Willem C Alffenaar, University Medical Center Groningen
University Medical Center Groningen
Not Provided
Not Provided
University Medical Center Groningen
January 2017