Pharmacokinetics of Micafungin in Critically Ill Patients

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2014 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: May 29, 2014

Last verified: May 2014

History of Changes

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:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Micafungin sodium Micafungin

Genetic and Rare Diseases Information Center resources: Systemic Candidiasis

U.S. FDA Resources

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:	November 2014
Estimated Primary Completion Date:	September 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:	May 29, 2014
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 Mycoses Micafungin	Anti-Infective Agents Antifungal Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015

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