NCT02172768

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	alternate dosing	treatment for 8 days with intravenous micafungin twice weekly
OTHER	daily dosing	micafungin daily for 8 days
DRUG	micafungin

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2014-06-24
• Last updated: 2020-12-08

Locations

2 sites across 2 countries: Belgium, Netherlands