Study on the Pharmacokinetic Characteristics of Liposomal Amphotericin B in Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy

Starting soon

Conditions studied: Invasive Fungal Infections

In brief

The goal of this prospective study is to describe the pharmacokinetic characteristics of liposomal amphotericin B during plasma exchange therapy for severe invasive fungal infections in Chinese patients, preliminarily explore the influencing factors of in vivo exposure variability of liposomal amphotericin B, and integrate the findings with efficacy and safety outcomes. The main questions it aims to answer is: Clarifying the correlation between the concentration, efficacy, and safety of different forms of liposomal amphotericin B in a special population, explore the changes in drug concentration mediated by plasma exchange, elucidate the mechanism of individual differences in efficacy and the optimal dosage, in order to provide a basis for personalized treatment of liposomal amphotericin B. The study plans to collect pharmacokinetic samples from 10 adult (aged ≥ 18 years) severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.

Key facts

Study ID

NCT07532850

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

10

Starts

2026-03-30

Expected to finish

2027-06-30

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old, gender not limited; According to < The Chinese guidelines for the diagnosis and treatment of invasive fungal disease in patients with hematological disorders and cancers (the 6th revision) >, the diagnosis is neutropenia with fever, possible, probable, and proven IFD invasive fungal disease;
• Currently receiving treatment with liposomal amphotericin B;
• Undertaking plasma exchange support therapy;
• Understand the research procedure and voluntarily sign a written informed consent form.

You may not qualify if…

• Confirmed patients with allergies/rapid onset severe allergic reactions/intolerance to AmB Subjects who are known to be insensitive or resistant to amphotericin B treatment, such as those with invasive Aspergillus terreus and Aspergillus nidulans

Full record on ClinicalTrials.gov

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