MedDataX Logo

Pharmacokinetics of Micafungin in Patients Intensive Care Unit

NCT ID: NCT01783379

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Fungal Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

invasive fungal infection micafungin intensive care pharmacokinetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU patient on micafungin

ICU patients with an invasive fungal infection on micafungin treatment

micafungin

Intervention Type DRUG

100mg/day infusion in 1 hour

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

micafungin

100mg/day infusion in 1 hour

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mycamine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

R Bruggemann

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rijstate Hospital

Arnhem, , Netherlands

Site Status

Gelderse Vallei Hospital

Ede, , Netherlands

Site Status

Canisius Wilhelmina Ziekenhuis

Nijmegen, , Netherlands

Site Status

Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Lempers VJ, Schouten JA, Hunfeld NG, Colbers A, van Leeuwen HJ, Burger DM, Verweij PE, Pickkers P, Bruggemann RJ. Altered Micafungin Pharmacokinetics in Intensive Care Unit Patients. Antimicrob Agents Chemother. 2015 Aug;59(8):4403-9. doi: 10.1128/AAC.00623-15. Epub 2015 May 11.

Reference Type RESULT
PMID: 25963988 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UMCN AKF 12.05

Identifier Type: -

Identifier Source: org_study_id