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

NCT07532850 | Not Yet Recruiting

• 1 other identifier: QTJC2025008
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Invasive Fungal Infections

Keywords

plasma exchange; invasive fungal infection; liposomal amphotericin B; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.

  Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy. Plot the concentration time data and mean values of amphotericin B from different time samples of each patient, along with a list of standard deviations. Using a non-compartmental model method, fit the drug time data of each patient and component using Phoenix WinNonlin software. Calculate the following pharmacokinetic parameters, mean values, and standard deviations: • Maximum blood drug concentration (Cmax)

  through study completion, an average of 2 years

Secondary Outcomes (4)

• Pharmacokinetic characteristics of liposomal amphotericin B in patients with severe invasive fungal infections undergoing plasma exchange therapy.

  Through study completion, an average of 2 years

• Time to reach maximum blood drug concentration

  Through study completion, an average of 2 years

• the area under the blood drug concentration time curve during the dosing cycle and up to infinity

  Through study completion, an average of 2 years

• Terminal elimination of half-life

  Through study completion, an average of 2 years

Study Arms (1)

invasive fungal infection patients

Severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy

Other: Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.

Interventions

Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy. OTHER

Collection of pharmacokinetic samples to explore the pharmacokinetic characteristics in severe invasive fungal infection patients receive liposomal amphotericin B who undergo plasma exchange therapy.

invasive fungal infection patients

Eligibility Criteria

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

Study Population

critically ill patients with invasive fungal infections undergoing plasma exchange therapy who receive liposomal amphotericin B therapy

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Central Study Contacts

wenjuan miao, Doctor

CONTACT

+86 18622691362; miaowenjuan@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: April 16, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share