drugset / Trial / NCT02172768

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

NCT02172768

Phase 2 Completed 30 enrolled Radboud University Medical Center
RandomizedParallel-groupOpen-labelOther

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

Timeline

Start
2014-10
Primary completion
2016-06
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Micafungin Peptide 100 mg Intravenous
Subject Micafungin Peptide 300 mg Intravenous