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

NCT07656493 | Not Yet Recruiting

• 1 other identifier: KC2025-JX-0390WLH-06
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Invasive Fungal Infection; Solid Organ Transplantation; Opportunistic Infections

Keywords

Liposomal Amphotericin B; Solid Organ Transplantation; Invasive Fungal Disease; Antifungal Therapy; Tacrolimus; Cyclosporine; Therapeutic Drug Monitoring; Drug-Drug Interaction; Real-World Study; Transplant Infection

Outcome Measures

Primary Outcomes (2)

• 28-Day Clinical Response Rate

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

  Day 28

• 84-Day All-Cause Mortality

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

  Day 84

Secondary Outcomes (8)

• Mycological Clearance Rate

  Day 28

• Acute Kidney Injury

  Baseline through Day 84

• Electrolyte Abnormalities

  Baseline through Day 84

• Liposomal Amphotericin B Plasma Concentration

  Baseline through Day 84

• Association Between Liposomal Amphotericin B Exposure and Clinical Response

  Baseline through Day 84

Study Arms (2)

Liposomal Amphotericin B Cohort

Solid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy.

Drug: Liposomal Amphotericin B

Historical Control Cohort

Historical control patients with invasive fungal disease treated with alternative systemic antifungal regimens.

Drug: Alternative Systemic Antifungal Therapy

Interventions

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.

Also known as: L-AmB

Liposomal Amphotericin B Cohort

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.

Also known as: Azoles, Echinocandins

Historical Control Cohort

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

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.

You may qualify if:

• 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.
• Provision of informed consent for prospective participants.

You may not qualify if:

• 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.
• Participation judged inappropriate by the investigator.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Beijing Science and Technology Innovation Medical Development Foundation: collaborator

Study Sites (1)

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Related Publications (1)

• Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg BJ, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, Roilides E, Ruhnke M, Prokop CS, Shoham S, Slavin MA, Stevens DA, Thompson GR, Vazquez JA, Viscoli C, Walsh TJ, Warris A, Wheat LJ, White PL, Zaoutis TE, Pappas PG. Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376. doi: 10.1093/cid/ciz1008.

  PMID: 31802125 BACKGROUND

MeSH Terms

Conditions

Invasive Fungal Infections; Opportunistic Infections

Interventions

liposomal amphotericin B; Azoles; Echinocandins

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lingai Pan, MD

  Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingai Pan, MD

CONTACT

+86 17708130236; panlingai2004@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Organ Donation Program

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)