NCT02651038

Brief Summary

Micafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of this class of antifungal agents are known to inhibit the synthesis of glucan polymers in fungal cell walls. The spectrum of activity of micafungin includes Candida (all species, including strains resistant to fluconazole), Aspergillus, and Pneumocystis. In intensive care patients continuous venovenous haemodiafiltration (CVVHDF) is a well-established extracorporal renal replacement therapy with a high clearance rate. Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHDF are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used. Ten intensive-care patients with acute renal failure and suspected or proven candida infection are included into the study. 100 mg Micafungin will be infused over a period of sixty minutes via a central venous catheter, different from the venous catheter used for CVVHDF. Blood samples will be drawn on days 1 and 2 from the arterial and venous line of the extracorporeal circuit at 0, 2, 4, 6, 8 and 24h after starting the infusion. Plasma and ultrafiltration samples, collected from the outlet of the ultrafiltrate compartment of the hemofilter, will be taken at corresponding times. The following pharmacokinetic parameters will be determined: area under the curve (AUC), half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

May 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

July 17, 2015

Last Update Submit

January 7, 2016

Conditions

Candida Sepsis

Outcome Measures

Primary Outcomes (1)

  • Haemofiltration clearance of Micafungin

    Haemofiltration clearance in ml/min measured by micafungin concentration gradient between hemodialyzer inlet and outlet port.

    49 hours

Study Arms (1)

Micafungin

EXPERIMENTAL

Micafungin is administered per clinical need and the pharmacokinetic parameters are analyzed

Drug: Micafungin

Interventions

MicafunginDRUG

Measurement of PK

Micafungin

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 to 70 years
  • Suspected or proven candida infection requiring parenteral antifungal therapy.
  • Continuous venovenous hemo(dia)filtration or Cica HD because of an acute renal failure.

You may not qualify if:

  • Known history of hypersensitivity to echinocandins.
  • An expected survival of less than three days.
  • Known alcohol dependency
  • Known epilepsy
  • Known pregnancy
  • Known liver failure
  • Soor oesophagitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1190, Austria

Location

Related Publications (1)

  • Vossen MG, Knafl D, Haidinger M, Lemmerer R, Unger M, Pferschy S, Lamm W, Maier-Salamon A, Jager W, Thalhammer F. Micafungin Plasma Levels Are Not Affected by Continuous Renal Replacement Therapy: Experience in Critically Ill Patients. Antimicrob Agents Chemother. 2017 Jul 25;61(8):e02425-16. doi: 10.1128/AAC.02425-16. Print 2017 Aug.

    PMID: 28584142DERIVED

MeSH Terms

Interventions

Micafungin

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Florian Thalhammer, Prof. Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

July 17, 2015

First Posted

January 8, 2016

Study Start

May 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

AU(1)