Population Pharmacokinetics of L-AmB in Chinese Patients Assisted by Extracorporeal Membrane Pulmonary Oxygenation (ECMO)

December 30, 2024 updated by: Lin Yang, Beijing Anzhen Hospital
The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The information of patient characteristics, physiological parameters, ECMO related parameters, administration and sampling information of L-AmB were collected.Patients were intravenously titrated after 3 doses of maintenance dose titration. The sampling window was from 0 to 24 h. The time points were 0.5 h before and 1, 2, 3, 6, 9, 12, 16, 20 and 24 h after administration. NONMEM software was applied to establish the PPK model of L-AmB.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnostic criteria for invasive fungal infections presenting to the intensive care unit (ICU) with probable or proved patients According to the 2021 EORTC/MSGERC guideline.
  • Requiring ECOM assistance.
  • Age 18 years.

Exclusion Criteria:

  • Intolerance of L-AmB therapy.
  • Pregnancy.
  • Expected survival time <24 hours.
  • Lack of necessary data on patient demographics physiopathology, and clinical status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-AmB group
To establish and validate a population pharmacokinetic model for L-AmB in patients with severe invasive fungal infections treated undergoing ECMO-assisted therapy.
Biological: Determination of blood drug concentration
Collecting blood samples from patients and determining blood drug concentrations. Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration. Then, the blood concentrations were determined according to the established method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood drug concentration of liposomal amphotericin B
Time Frame: The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration.
Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. Then collecting blood samples from these patients. The blood concentrations of L-AmB were determined according to the established method.
The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2025

Primary Completion (Estimated)

November 11, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANZHEN HOSPITOL-LY-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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