Pharmacokinetics of Micafungin During Continuous Venoveno... | NCT02651038

Studies
Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

NCT02651038

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 8, 2016Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Candida Sepsis

Interventions

Micafungin

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jul 17, 2015

First Submission Date that Met QC Criteria

Jan 7, 2016

First Posted Date

Jan 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2016

Last Update Posted Date

Jan 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Florian Thalhammer, Prof. Dr., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Micafungin	Experimental	Micafungin is administered per clinical need and the pharmacokinetic parameters are analyzed	Drug: Micafungin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micafungin	Drug	Measurement of PK	Micafungin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Haemofiltration clearance of Micafungin	Haemofiltration clearance in ml/min measured by micafungin concentration gradient between hemodialyzer inlet and outlet port.	49 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Florian Thalhammer, Prof. Dr.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1190	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28584142	Derived	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.

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins