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

NCT06754436 | Not Yet Recruiting Phase 4

• 1 other identifier: ANZHEN HOSPITOL-LY-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Fungal Infections; Liposomal Amphotericin B

Outcome Measures

Primary Outcomes (1)

• Blood drug concentration of liposomal amphotericin B

  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.

Study Arms (1)

L-AmB group

EXPERIMENTAL

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

Interventions

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.

L-AmB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Yang Lin, PhD

CONTACT

86-010-64456609; linyang3623@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of pharmacy department of Beijing Anzhen Hospital

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 31, 2024
• Study Start: January 10, 2025
• Primary Completion: November 11, 2025
• Study Completion: February 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

CN (1)