NCT01783379

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

January 9, 2013

Last Update Submit

November 26, 2020

Conditions

Invasive Fungal Infection

Keywords

invasive fungal infectionmicafunginintensive carepharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • micafunigin AUC

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

    Day 3 and Day 7

Secondary Outcomes (3)

  • covariates

    17 days

  • exposure

    17 days

  • number of adverse events

    17 days

Study Arms (1)

ICU patient on micafungin

ICU patients with an invasive fungal infection on micafungin treatment

Drug: micafungin

Interventions

micafunginDRUG

100mg/day infusion in 1 hour

Also known as: Mycamine
ICU patient on micafungin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving micafungin for the treatment or suspicion of an invasive fungal infection will be included. At least 20 patients will be included to obtain 16 evaluable patients. If recruitment of 20 patients is achieved within one year, more patients can be included. A formal sample size cannot be performed for several reasons but the sample size is rather based on the general assumption that 16 patients are sufficient to have a descriptive PK approach.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rijstate Hospital

Arnhem, Netherlands

Location

Gelderse Vallei Hospital

Ede, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25963988RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for pharmacokinietic analysis will be collected

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Micafungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • R Bruggemann

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2013

First Posted

February 4, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

NL(4)