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

Study on the Pharmacokinetic Characteristics, Safety, and Efficacy of Liposomal Amphotericin B in Critically Ill Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Invasive Fungal Infections
• Intervention / Treatment: 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.

Detailed Description

1. Establishment of UPLC-MS/MS（Ultra Performance Liquid Chromatography-Tandem Mass Spectrometry） analysis method for amphotericin B in plasma. Due to various factors such as small sample size, low drug concentration, endogenous substance interference, and individual differences that affect the determination of in vivo samples, in order to ensure the reliability of the method, it is necessary to validate the method while establishing an in vivo sample analysis method.

   By systematically optimizing plasma sample pretreatment, chromatographic conditions, and mass spectrometry conditions, and conducting methodological investigations on specificity, minimum quantification limit, minimum detection limit, linear range, accuracy, precision, matrix effects, stability system, etc., an accurate, rapid, and highly sensitive UPLC-MS/MS method is established.

2. Study on the pharmacokinetic characteristics of amphotericin B liposomes in patients with severe invasive fungal infections undergoing plasma exchange therapy using traditional Chinese medicine Research subjects: The research subjects of this project are patients with severe invasive fungal infections receiving plasma exchange therapy. Plan to include 10 people.

   When the patient's dosage is stable, collect 4mL of intravenous blood from the EDTA-K2（Ethylenediaminetetraacetic acid dipotassium salt） collection tube within 1 hour before the administration of liposomal amphotericin B before plasma exchange, immediately after infusion, 1 hour, 6 hours, 12 hours after infusion, 5 minutes before and immediately after plasma exchange, immediately after the next infusion after plasma exchange, and 24 hours. Subsequent pharmacokinetic studies will be conducted.

3. Optimization of treatment plan for severe invasive fungal infections in patients receiving plasma exchange therapy with liposomal amphotericin B

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: wenjuan miao, Doctor; Phone Number: +86 18622691362; Email: miaowenjuan@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: • Blood drug concentration before next administration (Ctrough)	Through study completion, an average of 2 years
Time to reach maximum blood drug concentration	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: • Time to reach maximum blood drug concentration (Tmax)	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	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: The area under the blood drug concentration time curve during the dosing cycle and up to infinity (AUC0- τ and AUC 0- ∞, respectively)	Through study completion, an average of 2 years
Terminal elimination of half-life	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: Terminal elimination half-life (t1/2)	Through study completion, an average of 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pharmacokinetics; invasive fungal infection; plasma exchange; liposomal amphotericin B
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections
• Other Study ID Numbers: QTJC2025008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No