Pharmacokinetics of Micafungin Given Twice Weekly Intrave... | NCT02172768

Studies
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease

NCT02172768

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Dec 8, 2020Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Acute Graft Versus Host Disease Grade II-IV
Allogeneic Stem Cell Transplant
Acute Myeloid Leucaemia
Myelo Dysplastic Syndrome

Interventions

alternate dosing
daily dosing
micafungin

Countries

Belgium
Netherlands

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

Status Module

Record Verification Date

Dec 2020

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

Oct 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jun 20, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 24, 2014Estimated

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

Dec 4, 2020

Last Update Posted Date

Dec 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The primary objective of this trial is as follows:

To determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for Stem Cell Transplant (SCT); receiving first remission induction chemotherapy for Acute Myeloid Leucaemia (AML)/MyeloDysplasticSyndrome (MDS)) compared to the pharmacokinetics of micafungin given daily.

The secondary objective of this trial is as follows:

To determine whether adequate exposure of micafungin is attained. To determine the safety of micafungin in this patient population

Detailed Description

Micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (HSCT) recipients and has proven as effective as fluconazole for prophylaxis. Whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. Sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. Decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages.

It will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
alternate dosing	Experimental	treatment for 8 days with intravenous micafungin twice weekly	Other: alternate dosing Drug: micafungin
daily dosing	Active Comparator	micafungin daily for 8 days	Other: daily dosing Drug: micafungin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alternate dosing	Other	treatment for 8 days with intravenous micafungin twice weekly	alternate dosing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area under the curve	Full pharmacokinetic curves will be taken op Day 4 or 5 and Day 8 (micafungin). AUC of two dosing regimens will be compared.	day 4 and day 8

Secondary Outcomes

Measure	Description	Time Frame
population PK model	to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting	Day 4 and Day 8
adverse events	number and severity of adverse events will be recorded during the study and both treatment regimens will be compared

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient receives immunosuppressive therapy for acute GvHD grade II-IV or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for AML/MDS.
Subject is at least 18 of age on the day of providing informed consent.
Has no signs or symptoms of invasive fungal disease
If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
Less than 1 week of immunosuppressive therapy for grade II-IV acute GvHD.
Is managed with a central venous catheter (preferably a quadruple Arrow-Howes™ Quad-Lumen 8.5,5 French; Arrow International).
Subject is able and willing to sign the Informed Consent before screening evaluations.

Exclusion Criteria:

Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation.
History of or current abuse of drugs, alcohol or solvents.
Inability to understand the nature of the trial and the procedures required.
Has not previously participated in this trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Roger Brüggemann	Radboud University Medical Center	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30137340	Result	Muilwijk EW, Maertens JA, van der Velden WJFM, Ter Heine R, Colbers A, Burger DM, Andes D, Theunissen K, Blijlevens NMA, Bruggemann RJM. Pharmacokinetics of extended dose intervals of micafungin in haematology patients: optimizing antifungal prophylaxis. J Antimicrob Chemother. 2018 Nov 1;73(11):3095-3101. doi: 10.1093/jac/dky324.

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven			Belgium
Radboudumc

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D054714	Echinocandins
D010456	Peptides, Cyclic