Skip to main content
OpenTrials
Completed

NCT Number: NCT01783379

Pharmacokinetics of Micafungin in Patients Intensive Care Unit

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Invasive Fungal Infection Bacterial Infections and Mycoses Infections Invasive Fungal Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijstate Hospital, Arnhem, Netherlands

Loading trial locations.

About this study

Whilst micafungin (Mycamine®) has much to offer, little is known about its pharmacokinetic profile in ICU patients with specific co-morbidities such as obesity, hypoalbumenia, and severe liverfunction disturbances. Also, ICU patients are known to experience changes in pharmacokinetics (PK) due to changes in hemodynamics, extracorporeal elimination techniques, interacting comedication, etc. Based on criteria outlined below, micafungin may prove to be the drug of choice in this cohort of patients. Therefore it seems prudent to conduct a trial in a cohort of patients who receive micafungin but with co-variates that may be of influence to the pharmacokinetic profile. To build a valid pharmacokinetic model, all patients on micafungin will be included in the analysis and used for model building. Co-variates that will be explored are at least: obesitas, liverfunction, albumin, creatinin-clearance. Simulations will be performed to determine if adequate exposure is reached under different patho-physiological conditions.

In conclusion: this trial is on determining the PK of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Most important covariates will be modelled using advanced mathematical techniques. Micafungin may prove to be beneficial over the other two echinocandins in terms of limited factors that impact PK. This has to be proven in a prospective trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is admitted to an ICU
  • Subject is at least 18 years of age on the day of the first dosing
  • If subject is female: neither pregnant nor able to become pregnant and is not nursing an infant
  • Subject has been treated with micafungin for a maximum of two days before enrolment in this trial
  • Is managed with a central venous catheter or an arterial catheter

Exclusion criteria

  • Is known to be hypersensitive to echinocandin antifungal agents
  • Documented history of sensitivity to excipients similar to those found in the micafungin preparation
  • Known of positive HIV test or positive hepatitis B or C test in history
  • History of or current abuse of drugs, alcohol or solvents
  • Has previously participated in this trial

Treatment and study plan

Micafungin

Drug

100mg/day infusion in 1 hour

Other names: Mycamine

Primary outcomes

  1. micafunigin AUC

    Time frame: Day 3 and Day 7

    AUC0-tau [mg*g/L] of micafungin given to ICU patients. Other pharmacokinetic parameters will be assessed as well.

Secondary outcomes

  1. covariates

    Time frame: 17 days

    co-variates of influence on the pharmacokinetics of micafungin. Specific co-variates are of high interest to the researchers: high body weight (including obese patients, defined as BMI> 30 kg/m2), hypo-albuminaemia, clearance pathways, impact of extracorporeal clearance system (ECMO, CVVH).

  2. exposure

    Time frame: 17 days

    To determine whether adequate exposure is attained in ICU patients

  3. number of adverse events

    Time frame: 17 days

    To determine the safety of micafungin in this patient population

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Pharmacokinetics of Micafungin (Mycamine ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates

Acronym: MIMIC

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.