Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Because anidulafungin 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 anidulafungin is approved for the treatment of invasive candidiasis in
adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese
patients are not available. Subsequently, the pharmacokinetic profile of anidulafungin (as
well as other echinocandins) in this specific patient population is still largely unknown.
During endoscopic gastric bypass surgery, patients are more prone to various kinds of
infection, justifying the prophylactic use of anidulafungin in this specific cohort of
patients.
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 anidulafungin (besides standard
anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be
compared to the pharmacokinetics in a normal-weight group.