Pharmacokinetics of Micafungin in Critically Ill Patients

Study Description

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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.

Condition or disease
Critical Illness; Invasive Candidiasis

Study Design

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Study Type :	Observational
Actual Enrollment :	19 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis
Study Start Date :	October 2012
Actual Primary Completion Date :	December 2016
Actual Study Completion Date :	January 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Micafungin

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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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

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Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

University Medical Center Groningen

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 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