Recruitment

Recruitment Status
Completed

Inclusion Criterias

Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
Subject is at least 18 years of age on the day of screening.
...
Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
Subject is at least 18 years of age on the day of screening.
If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.

Exclusion Criterias

Inability to understand the nature of the trial and the procedures required.
History of, or current abuse of drugs, alcohol or solvents.
Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
Inability to understand the nature of the trial and the procedures required.
History of, or current abuse of drugs, alcohol or solvents.
Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.

Summary

Conditions
Obesity Morbid
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

All obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. A PK curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12,...

All obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. A PK curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12, 24, and 48 and (if feasible) 72 hours post infusion (n=12 samples). Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.

Inclusion Criterias

Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
Subject is at least 18 years of age on the day of screening.
...
Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.
Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery.
Subject is at least 18 years of age on the day of screening.
If subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant.

Exclusion Criterias

Inability to understand the nature of the trial and the procedures required.
History of, or current abuse of drugs, alcohol or solvents.
Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.
Inability to understand the nature of the trial and the procedures required.
History of, or current abuse of drugs, alcohol or solvents.
Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation.

Locations

Nijmegen, Gelderland
Nieuwegein
Nijmegen, Gelderland
Nieuwegein

Tracking Information

NCT #
NCT02021123
Collaborators
Not Provided
Investigators
  • Principal Investigator: Roger JM Brüggemann, PharmD, PhD Radboud University
  • Roger JM Brüggemann, PharmD, PhD Radboud University