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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
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Morbid Drug: Anidulafungin 100mg single dose iv Phase 4

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.

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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

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. adverse events [ Time Frame: 0-72 h after dosing ]
    adverse events will be collected and reported



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
St. Antonius hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Roger JM Brüggemann, PharmD, PhD Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02021123     History of Changes
Other Study ID Numbers: UMCN-AKF 13.06
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Radboud University:
Anidulafungin
Gastric bypass
Morbidly obese
Pharmacokinetics
Prophylaxis
Yeast infection
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anidulafungin
Antifungal Agents
Anti-Infective Agents