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NCT Number: NCT01716988

Pharmacokinetics of Micafungin in Critically Ill Patients

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.

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Key information

Conditions

Critical Illness Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Disease Attributes Infections Invasive Candidiasis Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Blood sampling not possible.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Pharmacokinetic parameters of micafungin in ICU patients.

    Time frame: 4 days

    Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.

  2. Time (in days) to culture conversion.

    Time frame: max 28 days

    Number of days untill cultures are negative.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Oct 30, 2012
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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