Clinical Research Directory

Inclusion Criteria Patients must meet all of the following criteria to be eligible for enrollment: 1. Willing to participate in the study and able to provide written informed consent; 2. Hospitalized patients admitted to the intensive care unit (ICU); 3. Age ≥ 18 years, with no restriction on sex; 4. 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: 1. 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); 2. 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: 1. 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 \[COPD\]); 2. 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); 3. At least one compatible radiological finding (e.g., newly developed pulmonary infiltrates on chest computed tomography, or cavitary lesions not explained by other causes); 4. 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). 5. Concomitant hepatic dysfunction meeting at least one of the following conditions: * Aminotransferase levels \>3 times the upper limit of normal (ULN) and \<10 times ULN; * Child-Pugh class A or B; 6. Expected to receive antifungal therapy for ≥5 days. Exclusion Criteria Patients meeting any of the following criteria will be excluded: 1. Pregnant or breastfeeding women; 2. Known allergy or hypersensitivity to amphotericin B or any of its formulations; 3. Previous treatment with extracorporeal membrane oxygenation (ECMO); 4. Expected life expectancy \<48 hours; 5. Patients who, at the time of enrollment, are confirmed to require antifungal agents other than those specified in the study protocol; 6. 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; 7. 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; 8. Participation in another clinical trial within 3 months prior to enrollment; 9. Previous enrollment in this study; 10. 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); 11. Any other condition deemed by the investigator to make the patient unsuitable for participation.