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Critical Illness | Pharmacokinetics of Micafungin in Critically Ill Patients

Critical Illness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Treatment with micafungin. - Admission to an ICU. - Age ≥ 18 years. - Invasive candidiasis. Exclusion Criteria: - Blood sampling not possible.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Invasive Candidiasis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Micafungin

Study Status

Completed

Start Date: October 2012

Completed Date: January 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.

Secondary Outcome: Pharmacokinetic parameters of micafungin in ICU patients.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University Medical Center Groningen

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01716988

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