drugset / Trial / NCT03102658

Micafungin Pharmacokinetics in Obese Patients

NCT03102658

Non-randomizedParallel-groupOpen-labelBasic science

Summary

Because micafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although micafungin is approved for the treatment of invasive candidiasis, dosing guidelines for micafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of micafungin (as well as other echinocandins) in this specific patient population is still largely unknown. To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg or 200mg micafungin (besides standard anti-bacterial prophylaxis) and samples for a pharmacokinetic curve will be taken. These PK-values can then be compared to the PK in a normal-weight group which will receive 100mg micafungin

Timeline

Start
2017-01
Primary completion
2017-07
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Micafungin Peptide 100 mg Intravenous
Subject Micafungin Peptide 200 mg Intravenous

Indications