NCT06754436

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Invasive Fungal Infections
• Liposomal Amphotericin B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-11-11
• Completion: 2026-02-01
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

1 site across 1 country: China