Liposomal Amphotericin B for Invasive Fungal Disease in Solid Organ Transplant Recipients (LAMB-SOT)

A Real-World Observational Study of the Effectiveness, Safety, and Immunosuppressant Therapeutic Drug Monitoring of Liposomal Amphotericin B in Solid Organ Transplant Recipients With Invasive Fungal Disease

This real-world observational study aims to evaluate the effectiveness and safety 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 immunosuppressive agents, including tacrolimus and cyclosporine. Drug concentrations, dose modifications, temporary discontinuation, and drug-level abnormalities 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, radiological improvement, acute kidney injury, electrolyte disturbances, treatment-related adverse events, hospitalization duration, healthcare resource utilization, and immunosuppressant management characteristics. The study is expected to provide real-world evidence regarding the clinical use of L-AmB in transplant recipients and support optimization of antifungal treatment strategies in this high-risk population.

Study Overview

• Status: Not yet recruiting
• Conditions: Opportunistic Infections; Invasive Fungal Infection; Solid Organ Transplantation
• Intervention / Treatment: Drug: Liposomal Amphotericin B; Drug: Alternative Systemic Antifungal Therapy

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Lingai Pan, MD; Phone Number: +86 17708130236; Email: panlingai2004@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
      • Contact: Lingai Pan, MD; Phone Number: +86 17708130236; Email: panlingai2004@163.com

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liposomal Amphotericin B Cohort; Solid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy.	Drug: Liposomal Amphotericin B; 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.; Other Names: L-AmB
Historical Control Cohort; Historical control patients with invasive fungal disease treated with alternative systemic antifungal regimens.	Drug: Alternative Systemic Antifungal Therapy; 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.; Other Names: Azoles; Echinocandins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological Clearance Rate	Proportion of participants with documented clearance of fungal pathogens.	Day 28
Acute Kidney Injury	Occurrence of acute kidney injury during antifungal treatment.	Baseline through Day 84
Electrolyte Abnormalities	Occurrence of hypokalemia, hypomagnesemia, or other treatment-related electrolyte disturbances.	Baseline through Day 84
Tacrolimus Trough Concentration	Changes in tacrolimus trough concentrations during antifungal therapy.	Baseline through Day 84
Cyclosporine Trough Concentration	Changes in cyclosporine trough concentrations during antifungal therapy.	Baseline through Day 84
Immunosuppressant Dose Modification	Frequency of dose adjustment, temporary discontinuation, or resumption of immunosuppressive agents.	Baseline through Day 84
Breakthrough Fungal Infection	Occurrence of breakthrough invasive fungal infection during antifungal therapy.	Baseline through Day 84
Antifungal Treatment Discontinuation Due to Adverse Events	Permanent discontinuation of antifungal therapy because of treatment-related adverse events.	Baseline through Day 84

Collaborators and Investigators

• Sponsor: Sichuan Provincial People's Hospital
• Collaborators: Beijing Science and Technology Innovation Medical Development Foundation
• Investigators: Principal Investigator: Lingai Pan, MD, Sichuan Provincial People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Tacrolimus; Therapeutic Drug Monitoring; Cyclosporine; Liposomal Amphotericin B; Drug-Drug Interaction; Solid Organ Transplantation; Invasive Fungal Disease; Antifungal Therapy; Real-World Study; Transplant Infection
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Opportunistic Infections; Peptides; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Peptides, Cyclic; Echinocandins; liposomal amphotericin B; Azoles
• Other Study ID Numbers: KC2025-JX-0390WLH-06 (Other Grant/Funding Number: Beijing Science and Technology Innovation Medical Development Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient confidentiality and institutional data protection requirements.

Drug and device information, study documents

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