Pharmacokinetics of Micafungin in Critically Ill Patients
1 other identifier
observational
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 8, 2012
CompletedFirst Posted
Study publicly available on registry
October 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJanuary 12, 2017
January 1, 2017
4.2 years
October 8, 2012
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Pharmacokinetic parameters of micafungin in ICU patients.
4 days
Time (in days) to culture conversion.
max 28 days
Correlation of the plasma concentration of micafungin with response to treatment.
max 28 days
Correlation of the plasma concentration of micafungin with inflammation parameters.
4 days
Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.
max 28 days
- +2 more secondary outcomes
Study Arms (1)
Micafungin
Eligibility Criteria
Adult patients with invasive candidiasis admitted to an intensive care unit.
You may qualify if:
- Treatment with micafungin.
- Admission to an ICU.
- Age ≥ 18 years.
- Invasive candidiasis.
You may not qualify if:
- Blood sampling not possible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Related Publications (1)
Boonstra JM, van der Elst KC, Veringa A, Jongedijk EM, Bruggemann 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):e01398-17. doi: 10.1128/AAC.01398-17. Print 2017 Dec.
PMID: 28971861DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD, PhD
Study Record Dates
First Submitted
October 8, 2012
First Posted
October 30, 2012
Study Start
October 1, 2012
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
January 12, 2017
Record last verified: 2017-01