Prophylaxis for patients at risk for invasive fungal infection due to gastric bypass surgery. MedDRA version: 17.1 Level: PT Classification code 10017533 Term: Fungal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: AmBisome
Pharmaceutical Form: Powder for concentrate for dispersion for infusion
INN or Proposed INN: Amphotericin B
CAS Number: 1397-89-3
Current Sponsor code: AmBisome
Other descriptive
Sponsors
Radboud university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has a BMI =40 kg/m2 and is undergoing bariatric surgery. 2. Subject is at least 18 years of age on the day of screening. 3. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to polyene antifungal agents. 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 six months before enrolment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine optimal dosing strategy (multiple dose) in obese patients trough Monte Carlo simulations based on the developed PK model. • To compare the PK of liposomal amphotericin B in obese patients to a normal weight reference population. ;Timepoint(s) of evaluation of this end point: Day 1,2 and 3 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the pharmacokinetics of liposomal amphotericin B administered as a single, intravenous dose (2 mg/kg or 3 mg/kg) to obese patients with a BMI = 40 kg/m2. ;Secondary Objective: • To determine optimal dosing strategy (multiple dose) in obese patients trough Monte Carlo simulations based on the developed PK model. • To compare the PK of liposomal amphotericin B in obese patients to a normal weight reference population. ;Primary end point(s): 1. Determine PK parameters (AUC, Cmax, Cmin, clearance, volume of distribution, half-life, elimination rate constant) after a single intravenous dose.;Timepoint(s) of evaluation of this end point: Day 1, 2 and 3 | — |
Countries
Netherlands
Contacts
Public ContactRoger Brüggemann
Radboud university medical center
Outcome results
None listed