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

• Status: Completed
• Trial end date: 2018-11-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Patient has a BMI ≥40 kg/m2 and is undergoing bariatric surgery

2. Subject is at least 18 of age on the day of screening.

3. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.

Exclusion Criteria:

1. Documented history of sensitivity to medicinal products or excipients similar to those found in the polyene preparation.

2. History of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment).

3. Inability to understand the nature of the trial and the procedures required.

4. Administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of one month before enrolment.