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

December 4, 2020 updated by: Radboud University Medical Center

Pharmacokinetics of Micafungin (Mycamin ®) as Antifungal Prophylaxis Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
Drug: micafungin
Other: alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
Other Names:
  • micafungin
ACTIVE_COMPARATOR: daily dosing
micafungin daily for 8 days
Drug: micafungin
Other: daily dosing
micafungin daily for 8 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
area under the curve
Time Frame: day 4 and day 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
population PK model
Time Frame: Day 4 and Day 8
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
Time Frame: day 1- 11
number and severity of adverse events will be recorded during the study and both treatment regimens will be compared
day 1- 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (ESTIMATE)

June 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MATADOR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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