Back to resultsPharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease (MATADOR)
Primary Purpose
Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant, Acute Myeloid Leucaemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
alternate dosing
daily dosing
micafungin
Sponsored by
About this trial
This is an interventional other trial for Acute Graft Versus Host Disease Grade II-IV focused on measuring pharmacokinetics, alternate dosing, micafungin
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.
Sites / Locations
- UZ Leuven
- Radboudumc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
alternate dosing
daily dosing
Arm Description
treatment for 8 days with intravenous micafungin twice weekly
micafungin daily for 8 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
population PK model
to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting
adverse events
number and severity of adverse events will be recorded during the study and both treatment regimens will be compared
Full Information
NCT ID
NCT02172768
First Posted
June 20, 2014
Last Updated
December 4, 2020
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02172768
Brief Title
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease
Acronym
MATADOR
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant, Acute Myeloid Leucaemia, Myelo Dysplastic Syndrome
Keywords
pharmacokinetics, alternate dosing, micafungin
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alternate dosing
Arm Type
Experimental
Arm Description
treatment for 8 days with intravenous micafungin twice weekly
Arm Title
daily dosing
Arm Type
Active Comparator
Arm Description
micafungin daily for 8 days
Intervention Type
Other
Intervention Name(s)
alternate dosing
Other Intervention Name(s)
micafungin
Intervention Description
treatment for 8 days with intravenous micafungin twice weekly
Intervention Type
Other
Intervention Name(s)
daily dosing
Intervention Description
micafungin daily for 8 days
Intervention Type
Drug
Intervention Name(s)
micafungin
Primary Outcome Measure Information:
Title
area under the curve
Description
Full pharmacokinetic curves will be taken op Day 4 or 5 and Day 8 (micafungin). AUC of two dosing regimens will be compared.
Time Frame
day 4 and day 8
Secondary Outcome Measure Information:
Title
population PK model
Description
to perform Monte Carlo simulations to provide the scientific background for alternate dosing strategies in the prophylactic setting
Time Frame
Day 4 and Day 8
Title
adverse events
Description
number and severity of adverse events will be recorded during the study and both treatment regimens will be compared
Time Frame
day 1- 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Brüggemann
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
30137340
Citation
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.
Results Reference
result
Learn more about this trial
Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease
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