Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction

NCT07337720 | Not Yet Recruiting DMC

• 1 other identifier: 2025ZDSYLL264-P01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Liposomal amphotericin B is an antifungal agent commonly used to treat invasive aspergillosis, a severe fungal infection associated with high mortality in critically ill patients. However, evidence regarding its safety and effectiveness in patients with hepatic dysfunction is limited. In China, patients diagnosed with invasive aspergillosis complicated by hepatic dysfunction will be recruited from multiple centers. Eligible patients will receive treatment with liposomal amphotericin B according to the study protocol. The safety and effectiveness of liposomal amphotericin B in this patient population will be evaluated. This study aims to provide clinical evidence to support antifungal treatment decisions for patients with invasive aspergillosis and impaired liver function.

Conditions

Aspergillosis Invasive

Keywords

Invasive Aspergillosis; Liposomal Amphotericin B; Hepatic Dysfunction; Critically Ill Patients; Antifungal Therapy

Outcome Measures

Primary Outcomes (1)

• 2 weeks Overall response rate

  Overall response rate

  from treatment begin to Week 2

Secondary Outcomes (2)

• 6 weeks Overall response rate

  from treatment begin to week 6

• 6 weeks Survival rate

  from treatment begin to week 6

Study Arms (1)

L-AmB group

EXPERIMENTAL

Patients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. During the follow-up period, investigators may decide to continue treatment with liposomal amphotericin B or switch to other antifungal agents based on the patients' clinical condition.

Drug: LIposomal amphotericin B (L-AmB) treatment

Interventions

LIposomal amphotericin B (L-AmB) treatment DRUG

Patients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. During the follow-up period, investigators may decide to continue treatment with liposomal amphotericin B or switch to other antifungal agents based on the patients' clinical condition.

L-AmB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible for enrollment:
• Willing to participate in the study and able to provide written informed consent;
• Hospitalized patients admitted to the intensive care unit (ICU);
• Age ≥ 18 years, with no restriction on sex;
• Proven or probable invasive aspergillosis (IA), defined as follows:
• Proven IA
• Proven IA is diagnosed if at least one of the following criteria is met:
• Histopathological or cytopathological evidence of invasive Aspergillus spp. hyphae in tissue specimens obtained from a sterile site or the lung (e.g., biopsy or needle aspiration), with confirmation by culture or polymerase chain reaction (PCR);
• Isolation of Aspergillus spp. by culture from a specimen obtained from a sterile site (e.g., biopsy or needle aspiration), with the lesion consistent with an infectious process.
• Probable IA
• Probable IA requires the presence of all of the following criteria:
• At least one host factor (e.g., COVID-19, influenza, solid malignancy, HIV infection with CD4 \<200 cells/µL, decompensated liver cirrhosis, or moderate to severe chronic obstructive pulmonary disease \[COPD\]);
• At least one compatible clinical feature (e.g., fever ≥38.3 °C lasting ≥3 days, pleuritic chest pain, dyspnea, hemoptysis, or worsening respiratory failure despite appropriate antibacterial therapy);
• At least one compatible radiological finding (e.g., newly developed pulmonary infiltrates on chest computed tomography, or cavitary lesions not explained by other causes);
• At least one mycological criterion (e.g., positive culture for Aspergillus spp. from bronchoalveolar lavage fluid \[BALF\], serum galactomannan \>0.5 optical density index \[ODI\], or BALF galactomannan ≥1.0 ODI).

You may not qualify if:

• Patients meeting any of the following criteria will be excluded:
• Pregnant or breastfeeding women;
• Known allergy or hypersensitivity to amphotericin B or any of its formulations;
• Previous treatment with extracorporeal membrane oxygenation (ECMO);
• Expected life expectancy \<48 hours;
• Patients who, at the time of enrollment, are confirmed to require antifungal agents other than those specified in the study protocol;
• Presence of any of the following severe comorbid conditions that may interfere with assessment of study efficacy or safety:
• Acute liver failure or acute decompensation of chronic liver failure;
• Known or suspected active pulmonary tuberculosis, cystic fibrosis, lung abscess, empyema, or obstructive pneumonia;
• Severe renal impairment, defined as any of the following:
• Creatinine clearance (CrCL) \<16 mL/min at enrollment;
• Requirement for hemodialysis, peritoneal dialysis, or other renal replacement therapy at enrollment;
• Participation in another clinical trial within 3 months prior to enrollment;
• Previous enrollment in this study;
• Any condition that may affect study compliance or outcome assessment (e.g., planned major surgery, or inability to comply with the study protocol due to disease severity or poor adherence);

Sponsors & Collaborators

• Southeast University, China: lead

MeSH Terms

Conditions

Liver Diseases

Interventions

liposomal amphotericin B; Therapeutics

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 13, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share