Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease
NCT ID: NCT02172768
Last Updated: 2020-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2014-10-31
2016-07-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
micafungin
daily dosing
micafungin daily for 8 days
daily dosing
micafungin daily for 8 days
micafungin
Interventions
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alternate dosing
treatment for 8 days with intravenous micafungin twice weekly
daily dosing
micafungin daily for 8 days
micafungin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Roger Brüggemann
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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UZ Leuven
Leuven, , Belgium
Radboudumc
Nijmegen, , Netherlands
Countries
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References
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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.
Other Identifiers
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MATADOR
Identifier Type: -
Identifier Source: org_study_id