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

NCT ID: NCT02021123

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Morbid

Keywords

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Anidulafungin Gastric bypass Morbidly obese Pharmacokinetics Prophylaxis Yeast infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Anidulafungin 100 mg single dose

100 mg single dose anidulafungin pre-surgery (gastric bypass)

Group Type EXPERIMENTAL

Anidulafungin 100mg single dose iv

Intervention Type DRUG

Anidulafungin 100mg single dose iv pre-surgery (gastric bypass)

Interventions

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Anidulafungin 100mg single dose iv

Anidulafungin 100mg single dose iv pre-surgery (gastric bypass)

Intervention Type DRUG

Other Intervention Names

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Ecalta

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger JM Brüggemann, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

St. Antonius hospital

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

References

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Lempers VJ, van Rongen A, van Dongen EP, van Ramshorst B, Burger DM, Aarnoutse RE, Knibbe CA, Bruggemann RJ. Does Weight Impact Anidulafungin Pharmacokinetics? Clin Pharmacokinet. 2016 Oct;55(10):1289-1294. doi: 10.1007/s40262-016-0401-8.

Reference Type RESULT
PMID: 27142114 (View on PubMed)

Other Identifiers

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UMCN-AKF 13.06

Identifier Type: -

Identifier Source: org_study_id