Study on the Pharmacokinetic Characteristics of Liposomal Amphotericin B in Patients With Invasive Fungal Infections Undergoing Plasma Exchange Therapy
NCT07532850 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2026-04-16
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
Interventions
- 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.
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-30
- Primary Completion
- 2026-12-31
- Completion
- 2027-06-30
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