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Pharmacokinetics of Micafungin in Patients Intensive Care Unit

NCT01783379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2020-11-30

No results posted yet for this study

Summary

In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Patients will receive micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7 (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK days, trough samples will be taken to determine the time to steady state. All samples will be taken just prior to the morning dose of micafungin. All infusion rates will be according to the SPC label information. Patients are considered to be evaluable if at least the first PK curve has been completed. Two moments of PK analysis will enable us to determine whether there is an increase over time in exposure if steady state has not been reached.

Conditions

  • Invasive Fungal Infection

Interventions

DRUG

micafungin

100mg/day infusion in 1 hour

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • R Bruggemann · Radboud University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783379 on ClinicalTrials.gov