Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT) (ADOPT)
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|ClinicalTrials.gov Identifier: NCT02021123|
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : October 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Morbid||Drug: Anidulafungin 100mg single dose iv||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Anidulafungin (Ecalta ®) Given Intravenously as Prophylaxis to Obese Patients With Risk of Invasive Fungal Infection Undergoing Gastric Bypass Surgery.|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Anidulafungin 100 mg single dose
100 mg single dose anidulafungin pre-surgery (gastric bypass)
Drug: Anidulafungin 100mg single dose iv
Anidulafungin 100mg single dose iv pre-surgery (gastric bypass)
Other Name: Ecalta
- anidulafungin area under the curve [ Time Frame: 0-72 h after single dose ]The primary outcome measurement will be the area under the plasma concentration-time curve (AUC) from time 0 to infinitive (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.
- Predict long-term exposure after repeated dosing by using a pharmacokinetic model of anidulafunign in obese patients by using AUC(0-inf), Cmax, elimination half-life and clearance. [ Time Frame: PK curve on day 1-3 ]Simulate pharmacokinetics of anidulafungin after obtaining all plasma concentrations using modeling software to predict long-term exposure. For this, area under the plasma concentration-time curve (AUC) from time 0 to infinitive (inf) post infusion (AUC0- inf), peak plasma concentration (Cmax), elimination half-life and clearance values of anidulafungin will be used (as calculated in outcome measure 1). The PK curve of day 1-3 will serve to calculate these values.
- adverse events [ Time Frame: 0-72 h after dosing ]adverse events will be collected and reported
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021123
|Radboud University Medical Center|
|Nijmegen, Gelderland, Netherlands|
|St. Antonius hospital|
|Principal Investigator:||Roger JM Brüggemann, PharmD, PhD||Radboud University|