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Liposomal Amphotericin B for Invasive Fungal Disease in Solid Organ Transplant Recipients

ConditionsInvasive Fungal InfectionSolid Organ TransplantationOpportunistic Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSichuan Provincial People's Hospital

About this trial

This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections.

This is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced.

The study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy.

The primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities.

The study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years.

Recipient of a solid organ transplant.

Diagnosis of invasive fungal disease (IFD) according to EORTC/MSGERC criteria.

Receiving liposomal amphotericin B therapy as part of routine clinical care.

Disqualifiers

Known hypersensitivity to amphotericin B formulations.

Severe hepatic dysfunction (ALT or AST >5× upper limit of normal, or total bilirubin >2× upper limit of normal).

Severe renal dysfunction requiring permanent discontinuation of antifungal therapy at baseline.

Pregnancy or breastfeeding.

Trial population

Adult solid organ transplant recipients diagnosed with proven, probable, or possible invasive fungal disease and treated with liposomal amphotericin B or alternative systemic antifungal therapy at Sichuan Provincial People's Hospital.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Liposomal Amphotericin B

    Drug

    Liposomal amphotericin B administered for treatment of proven, probable, or possible invasive fungal disease in solid organ transplant recipients according to routine clinical practice. Dose adjustment and treatment duration are determined by treating physicians.

  • Alternative Systemic Antifungal Therapy

    Drug

    Alternative systemic antifungal agents including azoles, echinocandins, or other standard antifungal therapies administered according to routine clinical practice in historical control patients with invasive fungal disease.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Liposomal Amphotericin B Cohort1 intervention
Group B: Historical Control Cohort1 intervention

Trial outcomes

Primary outcomes

1

28-Day Clinical Response Rate

Proportion of participants achieving complete or partial clinical response at Day 28 after initiation of antifungal therapy.

Time frame
Day 28
2

84-Day All-Cause Mortality

All-cause mortality occurring within 84 days after initiation of antifungal therapy.

Time frame
Day 84

Secondary outcomes

1

Mycological Clearance Rate

Proportion of participants with documented clearance of fungal pathogens.

Time frame
Day 28
2

Acute Kidney Injury

Occurrence of acute kidney injury during antifungal treatment.

Time frame
Baseline through Day 84
3

Electrolyte Abnormalities

Occurrence of hypokalemia, hypomagnesemia, or other treatment-related electrolyte disturbances.

Time frame
Baseline through Day 84
4

Liposomal Amphotericin B Plasma Concentration

Plasma concentration of liposomal amphotericin B measured during antifungal therapy.

Time frame
Baseline through Day 84

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Provincial People's Hospital

Lead sponsor

Beijing Science and Technology Innovation Medical Development Foundation

Collaborator

Source ClinicalTrials.gov

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