Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction (NCT07337720) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction
40 participantsStarted 2025-12-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);
Exclusion criteria
. 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:
. Severe renal impairment, defined as any of the following:
. Participation in another clinical trial within 3 months prior to enrollment;