Pharmacokinetics of Micafungin in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716988
• Other study ID #: NL39246.042.12
• Status: Completed
• Phase: N/A
• First received: October 8, 2012
• Last updated: January 11, 2017
• Start date: October 2012
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment with micafungin.

• Admission to an ICU.

• Age = 18 years.

• Invasive candidiasis.

Exclusion Criteria:

• Blood sampling not possible.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Critical Illness
• Invasive Candidiasis

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.	Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.	4 days	No
Secondary	Pharmacokinetic parameters of micafungin in ICU patients.	Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.	4 days	No
Secondary	Time (in days) to culture conversion.	Number of days untill cultures are negative.	max 28 days	No
Secondary	Correlation of the plasma concentration of micafungin with response to treatment.	Correlation of the level of micafungin concentration with outcome.	max 28 days	No
Secondary	Correlation of the plasma concentration of micafungin with inflammation parameters.	Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin.	4 days	No
Secondary	Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.	Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species.	max 28 days	No
Secondary	Composing a pharmacokinetic model of micafungin in critically ill patients.	Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples.	max 28 days	No
Secondary	Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.	Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.	28 days	No