Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction
ConditionAspergillosis Invasive
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoutheast University, China
About this trial
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.
Eligibility criteria
Qualifiers
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;
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- LIposomal amphotericin B (L-AmB) treatment
Treatment groups
40 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov