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

19. juni 2026 oppdatert av: Lingai Pan, Sichuan Provincial People's Hospital

A Real-World Observational Study of the Effectiveness, Safety, and 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, 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610072
        • Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Liposomal Amphotericin B Cohort
Solid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy.
Legemiddel: 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.
Andre navn:
  • L-AmB
Historical Control Cohort
Historical control patients with invasive fungal disease treated with alternative systemic antifungal regimens.
Legemiddel: 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.
Andre navn:
  • Azoles
  • Echinocandins

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
28-Day Clinical Response Rate
Tidsramme: Day 28
Proportion of participants achieving complete or partial clinical response at Day 28 after initiation of antifungal therapy.
Day 28
84-Day All-Cause Mortality
Tidsramme: Day 84
All-cause mortality occurring within 84 days after initiation of antifungal therapy.
Day 84

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mycological Clearance Rate
Tidsramme: Day 28
Proportion of participants with documented clearance of fungal pathogens.
Day 28
Acute Kidney Injury
Tidsramme: Baseline through Day 84
Occurrence of acute kidney injury during antifungal treatment.
Baseline through Day 84
Electrolyte Abnormalities
Tidsramme: Baseline through Day 84
Occurrence of hypokalemia, hypomagnesemia, or other treatment-related electrolyte disturbances.
Baseline through Day 84
Breakthrough Fungal Infection
Tidsramme: Baseline through Day 84
Occurrence of breakthrough invasive fungal infection during antifungal therapy.
Baseline through Day 84
Antifungal Treatment Discontinuation Due to Adverse Events
Tidsramme: Baseline through Day 84
Permanent discontinuation of antifungal therapy because of treatment-related adverse events.
Baseline through Day 84
Liposomal Amphotericin B Plasma Concentration
Tidsramme: Baseline through Day 84
Plasma concentration of liposomal amphotericin B measured during antifungal therapy.
Baseline through Day 84
Association Between Liposomal Amphotericin B Exposure and Clinical Response
Tidsramme: Baseline through Day 84
Relationship between liposomal amphotericin B plasma concentration and clinical response.
Baseline through Day 84
Association Between Liposomal Amphotericin B Exposure and Adverse Events
Tidsramme: Baseline through Day 84
Relationship between liposomal amphotericin B plasma concentration and treatment-related adverse events, including nephrotoxicity and electrolyte abnormalities.
Baseline through Day 84

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sichuan Provincial People's Hospital

Samarbeidspartnere

Beijing Science and Technology Innovation Medical Development Foundation

Etterforskere

  • Hovedetterforsker: Lingai Pan, MD, Sichuan Provincial People's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. mars 2028

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

5. juni 2026

Først innsendt som oppfylte QC-kriteriene

14. juni 2026

Først lagt ut (Faktiske)

18. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KC2025-JX-0390WLH-06 (Annet stipend/finansieringsnummer: Beijing Science and Technology Innovation Medical Development Foundation)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared due to patient confidentiality and institutional data protection requirements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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