Pharmacokinetics of Micafungin in Patients Intensive Care Unit

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Echinocandins; Micafungin

Criteria

Inclusion Criteria:

1. Patient is admitted to an ICU

2. Subject is at least 18 years of age on the day of the first dosing

3. If subject is female: neither pregnant nor able to become pregnant and is not nursing an infant

4. Subject has been treated with micafungin for a maximum of two days before enrolment in this trial

5. Is managed with a central venous catheter or an arterial catheter

Exclusion Criteria:

1. Is known to be hypersensitive to echinocandin antifungal agents

2. Documented history of sensitivity to excipients similar to those found in the micafungin preparation

3. Known of positive HIV test or positive hepatitis B or C test in history

4. History of or current abuse of drugs, alcohol or solvents

5. Has previously participated in this trial