iposomal amphotericin B (Ambisome) pharmacokinetics given as a single intravenous dose to obese patients (ASPEN).

Phase 4

Completed

• Conditions: Aspergillosis / Invasive Fungal Infection; 10017528

• Registration Number: NL-OMON47120
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-11-03
• Results First Posted: 2019-05-30
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1. Patient has a BMI *40 kg/m2 and is undergoing bariatric surgery.
2. Subject is at least 18 years of age on the day of screening.
3. 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 polyene antifungal agents.
2. History of, or current abuse of drugs, alcohol or solvents (up until a maximum of three months before enrolment).
3. Inability to understand the nature of the trial and the procedures required.
4. Administration of nephrotoxic medication (aminoglycosids, immunosuppressants, antivirals, antineoplastic agents) up until a maximum of one month before enrolment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measurement will be area under the plasma concentration*<br /><br>time curve (AUC) from time 0 to infinitive (inf) post infusion (AUC0* inf)<br /><br>values of AmBisome. The AUC0inf will be determined by use of the linear up, log<br /><br>down trapezoidal rule. Peak plasma concentrations (Cmax) will be directly<br /><br>observed from the data. The elimination rate constant (ke) will be determined<br /><br>by linear regression of the terminal points of the log-linear plasma<br /><br>concentration time curve. Clearance (CL) will be calculated as dose/AUC0* inf.<br /><br>Volume of distribution (Vd) will be calculated as dose/AUC0-inf * ke. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>