Aspergillosis InvasiveNCT07337720
Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction
A study testing LIposomal amphotericin B (L-AmB) treatment in people with Aspergillosis Invasive, run by Southeast University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspergillosis Invasive
- What is being tested?
- LIposomal amphotericin B (L-AmB) treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria to be eligible for enrollment:
- 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:
- Proven IA
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- Proven IA is diagnosed if at least one of the following criteria is met:
- 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.
- Probable IA
- Probable IA requires the presence of all of the following criteria:
- 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);
- At least one compatible radiological finding (e.g., newly developed pulmonary infiltrates on chest computed tomography, or cavitary lesions not explained by other causes);
- 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).
- 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;
- Expected to receive antifungal therapy for ≥5 days.
Who cannot join
- Patients meeting any of the following criteria will be excluded:
- 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;
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- 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;
- 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;
- Participation in another clinical trial within 3 months prior to enrollment;
- Previous enrollment in this study;
- 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);
- Any other condition deemed by the investigator to make the patient unsuitable for participation.
About this study
Official title: Liposomal Amphotericin B in Patients With Invasive Aspergillosis and Hepatic Dysfunction: A Prospective Study
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.
Read the 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.
- Conditions
- Aspergillosis Invasive
- Being tested
- LIposomal amphotericin B (L-AmB) treatment
- Keywords
- Invasive Aspergillosis, Liposomal Amphotericin B, Hepatic Dysfunction, Critically Ill Patients, Antifungal Therapy
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIposomal amphotericin B (L-AmB) treatmentDrug
Patients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. 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.
| Study group | Role | What they receive |
|---|---|---|
| L-AmB group | Experimental | Patients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. 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. Receives: Drug: LIposomal amphotericin B (L-AmB) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 weeks Overall response rate
Overall response rate
Measured: from treatment begin to Week 2
Secondary outcomes (2)
6 weeks Overall response rate
Overall response rate
Measured: from treatment begin to week 6
6 weeks Survival rate
Survival rate
Measured: from treatment begin to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start20 Dec 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspergillosis InvasiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337720
- Sponsor's protocol ID
- 2025ZDSYLL264-P01
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Amphotericin B in Patients With Invasive Aspergillosis and Hepatic Dysfunction: A Prospective Study
- ClinicalTrials.gov ID
- NCT07337720
- Acronym / sponsor ID
- 2025ZDSYLL264-P01
- Conditions
- Aspergillosis Invasive
- Keywords
- Invasive Aspergillosis, Liposomal Amphotericin B, Hepatic Dysfunction, Critically Ill Patients, Antifungal Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-AmB group | Experimental | Drug: LIposomal amphotericin B (L-AmB) treatmentPatients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- Proven IA
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIposomal amphotericin B (L-AmB) treatmentPatients with invasive aspergillosis complicated by hepatic dysfunction who are admitted to the intensive care unit (ICU) will be treated with liposomal amphotericin B (L-AmB) at a dose of 3 mg/kg/day administered by intravenous infusion for 2 weeks. Patients will then enter a 4-week follow-up period. 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. | Drug | L-AmB group |
Primary outcome
2 weeks Overall response rate
Time frame: from treatment begin to Week 2
Overall response rate
2 secondary outcomes
6 weeks Overall response rate
Time frame: from treatment begin to week 6
6 weeks Survival rate
Time frame: from treatment begin to week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LIposomal amphotericin B (L-AmB) treatment in people with Aspergillosis Invasive, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 weeks Overall response rate (time frame: from treatment begin to Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.