Liposomal Amphotericin B (AmBisome) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ASPEN)

Summary

Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of AmBisome 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 1 mg/kg or 2 mg/kg AmBisome (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics of a normal-weight group.

Timeline

Start

2018-03-22

Primary completion

2018-11-03

Completion

2018-11-03

Publications

• Background Wasmann RE, Smit C, van Dongen EPH, Wiezer RMJ, Adler-Moore J, de Beer YM, Burger DM, Knibbe CAJ, Bruggemann RJM. Fixed Dosing of Liposomal Amphotericin B in Morbidly Obese Individuals. Clin Infect Dis. 2020 May 6;70(10):2213-2215. doi: 10.1093/cid/ciz885.

Drugs

Indications