NCT02320604

Brief Summary

Dosing guidelines for liposomal amphotericin B (AmBisome) in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of AmBisome in this specific patient population is still largely unknown. To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 1 mg/kg or 2 mg/kg AmBisome (besides standard anti-bacterial prophylaxis) and a PK-curve will be drawn. These PK-values can then be compared to the pharmacokinetics of a normal-weight group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
3.3 years until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2018

Completed
Last Updated

October 19, 2020

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

October 31, 2014

Last Update Submit

October 16, 2020

Conditions

Morbid Obesity

Keywords

Liposomal amphotericin BAmBisomePharmacokineticsObesityBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Area Under Curve (AUC) 0-inf Ambisome

    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 AmBisome. This will be determined by use of the log-linear trapezoidal rule.

    at t = 0.5, 0.75, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 and (if feasible) 72 hours post infusion

Secondary Outcomes (1)

  • Peak Plasma Concentration (Cmax) Ambisome

    at t = 0.5, 0.75, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 and (if feasible) 72 hours post infusion

Study Arms (2)

Obese Subjects 1mg/kg

EXPERIMENTAL

8 obese subjects will receive 1mg/kg Ambisome i.v. infused over 45 minutes

Drug: Administration of study drug

Obese Subjects 2mg/kg

EXPERIMENTAL

8 obese subjects will receive 2mg/kg Ambisome i.v. infused over 90 minutes

Drug: Administration of study drug

Interventions

Administration of study drugDRUG

i.v. administration of Ambisome in two different dossages

Also known as: Ambisome
Obese Subjects 1mg/kgObese Subjects 2mg/kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a BMI ≥40 kg/m2 and is undergoing bariatric surgery
  • Subject is at least 18 of age on the day of screening.
  • Subject or legal representatives are able and willing to sign the Informed Consent before screening evaluations.

You may not qualify if:

  • Documented history of sensitivity to medicinal products or excipients similar to those found in the polyene preparation.
  • History of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment).
  • Inability to understand the nature of the trial and the procedures required.
  • Administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of one month before enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

St. Antonius hospital

Nieuwegein, Netherlands

Location

Related Publications (1)

  • Wasmann RE, Smit C, van Dongen EPH, Wiezer RMJ, Adler-Moore J, de Beer YM, Burger DM, Knibbe CAJ, Bruggemann RJM. Fixed Dosing of Liposomal Amphotericin B in Morbidly Obese Individuals. Clin Infect Dis. 2020 May 6;70(10):2213-2215. doi: 10.1093/cid/ciz885.

    PMID: 31588493BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

liposomal amphotericin B

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roeland E Wasmann, PharmD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

December 19, 2014

Study Start

March 22, 2018

Primary Completion

November 3, 2018

Study Completion

November 3, 2018

Last Updated

October 19, 2020

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

No plan has been made. Individual researchers are welcome to request data with our group.

Locations

NL(2)