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

NCT06754436 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2025-11-11
Completion
2026-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06754436 on ClinicalTrials.gov