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Anidulafungin Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (ADOPT)

Information source: Radboud University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity Morbid

Intervention: Anidulafungin 100mg single dose iv (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
Roger JM Brüggemann, PharmD, PhD, Principal Investigator, Affiliation: Radboud University

Summary

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.

Clinical Details

Official title: Pharmacokinetics of Anidulafungin (Ecalta ) Given Intravenously as Prophylaxis to Obese Patients With Risk of Invasive Fungal Infection Undergoing Gastric Bypass Surgery.

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: anidulafungin area under the curve

Secondary outcome: 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.

Detailed 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, 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patient has a BMI ≥40 kg/m2 and is undergoing endoscopic gastric bypass 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: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin 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.

Locations and Contacts

St. Antonius hospital, Nieuwegein, Netherlands

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

Additional Information

Starting date: August 2014
Last updated: October 27, 2014

Page last updated: August 20, 2015

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