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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Intolerance of L-AmB therapy.

Pregnancy.

Expected survival time <24 hours.

Lack of necessary data on patient demographics physiopathology, and clinical status.

Trial design

Treatments tested in this trial

  • Determination of blood drug concentration

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators