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NCT Number: NCT06754436

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

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.

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Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Liposomal Amphotericin B Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Determination of blood drug concentration

Biological

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Lin, PhD

CONTACT

[email protected]

86-010-64456609

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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