Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • LIposomal amphotericin B (L-AmB) treatment

    Drug

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: L-AmB groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2 weeks Overall response rate

Overall response rate

Time frame
from treatment begin to Week 2

Secondary outcomes

1

6 weeks Overall response rate

Overall response rate

Time frame
from treatment begin to week 6
2

6 weeks Survival rate

Survival rate

Time frame
from treatment begin to week 6

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southeast University, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: