A Phase 2 interventional study of alternate dosing and daily dosing in Acute Graft Versus Host Disease Grade II-IV, Allogeneic Stem Cell Transplant and Acute Myeloid Leucaemia, sponsored by Radboud University Medical Center. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Radboud University Medical Center · Phase 2, Interventional, and Other
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
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.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
treatment for 8 days with intravenous micafungin twice weekly
Other: alternate dosing · Drug: micafungin
micafungin daily for 8 days
Other: daily dosing · Drug: micafungin
treatment for 8 days with intravenous micafungin twice weekly
Also known as: micafungin
micafungin daily for 8 days
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.
Time frame: day 4 and day 8
population PK model
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
adverse events
number and severity of adverse events will be recorded during the study and both treatment regimens will be compared
Time frame: day 1- 11
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center