Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:09 AM
Study NCT ID:
NCT07337720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction
Sponsor:
Southeast University, China
Organization:
Study Overview
Official Title:
Liposomal Amphotericin B in Patients With Invasive Aspergillosis and Hepatic Dysfunction: A Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This is a prospective, open-label, multicenter, single-arm exploratory clinical study designed to evaluate the safety and effectiveness of liposomal amphotericin B (L-AmB) in critically ill patients with invasive aspergillosis complicated by hepatic dysfunction.
The study will be conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. After approval by the ethics committees at all participating centers, eligible patients will be enrolled from 12 tertiary hospitals in China. Adult patients admitted to the intensive care unit (ICU) with a diagnosis of proven or probable invasive aspergillosis and concomitant hepatic dysfunction will be included according to predefined diagnostic and eligibility criteria.
All enrolled patients will receive liposomal amphotericin B as antifungal therapy at a dose of 3 mg/kg/day administered by intravenous infusion for a planned treatment duration of 2 weeks. Following completion of the initial treatment period, patients will enter a 4-week follow-up phase. 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, liver function status, and current clinical practice guidelines.
Patients will be followed prospectively to assess treatment response, survival, and safety outcomes. The primary outcome of the study is overall response rate at Week 2 after initiation of liposomal amphotericin B therapy. Secondary outcomes include overall response rate at Week 6, survival rate at Week 6, clinical response, mycological response, changes in liver function parameters, incidence of adverse events and serious adverse events, length of intensive care unit stay, and overall survival.
This study aims to generate real-world clinical evidence on the use of liposomal amphotericin B in patients with invasive aspergillosis and hepatic dysfunction and to support optimized antifungal treatment strategies for this high-risk population in the intensive care setting.
The study will be conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. After approval by the ethics committees at all participating centers, eligible patients will be enrolled from 12 tertiary hospitals in China. Adult patients admitted to the intensive care unit (ICU) with a diagnosis of proven or probable invasive aspergillosis and concomitant hepatic dysfunction will be included according to predefined diagnostic and eligibility criteria.
All enrolled patients will receive liposomal amphotericin B as antifungal therapy at a dose of 3 mg/kg/day administered by intravenous infusion for a planned treatment duration of 2 weeks. Following completion of the initial treatment period, patients will enter a 4-week follow-up phase. 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, liver function status, and current clinical practice guidelines.
Patients will be followed prospectively to assess treatment response, survival, and safety outcomes. The primary outcome of the study is overall response rate at Week 2 after initiation of liposomal amphotericin B therapy. Secondary outcomes include overall response rate at Week 6, survival rate at Week 6, clinical response, mycological response, changes in liver function parameters, incidence of adverse events and serious adverse events, length of intensive care unit stay, and overall survival.
This study aims to generate real-world clinical evidence on the use of liposomal amphotericin B in patients with invasive aspergillosis and hepatic dysfunction and to support optimized antifungal treatment strategies for this high-risk population in the intensive care setting.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: