Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07337720
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07337720
Study Brief:
Protocol Section:
NCT07337720