Candidiasis / Fungal infections
Conditions
Interventions
Inserting indwelling venous cannula/venflon for study.
A single dose of anidulafungin 100 mg administered according to SPC
(pre-operative).
A PK curve will be determined after administration of a si
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
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. If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant. 4. Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the anidulafungin preparation. 2. History of or current abuse of drugs, alcohol or solvents. 3. Inability to understand the nature of the trial and the procedures required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measurement will be the area under the plasma concentration- time curve (AUC) from time 0 to infinity (inf) post infusion (AUC0- inf) value of anidulafungin. This will be determined by use of the log-linear trapezoidal rule. Peak plasma concentrations (Cmax) will be directly observed from the data. The elimination rate constant will be determined by linear regression of the terminal points of the log-linear plasma concentration time curve. Clearance (CL) will be calculated as dose/AUC0- inf. | — |
Countries
Netherlands
Outcome results
None listed