To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation

Study Overview
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Brief Summary
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To evaluate the clinical success rate of micafungin in preventing invasive mycosis after liver transplantation.

Official Title
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To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: Micafungin Sodium 50 MG Injection
* Drug: Caspofungin Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent form voluntarily; Liver transplant patients with 1 high-risk factor; A. Transplant again; B. Fulminant liver failure; C. Renal failure requires alternative treatment (defined as creatinine clearance ≤40 ml/min); D. ICU duration before liver transplantation≥48h; E. Have received abdominal surgery within one month before liver transplantation or; F. Common bile duct jejunostomy (except for children); G. Excessive blood transfusion (blood transfusion exceeds 2000mL); H. The donor's ICU hospital stay exceeds 5 days; I. Positive sputum and blood culture of the donor J. The donor has evidence of lung or bloodstream infection (pulmonary infection is evaluated according to the diagnostic criteria and treatment principles (draft) of invasive lung fungal infection, and bloodstream infection is evaluated according to invasive fungal disease of patients with hematopathy/malignant tumor Diagnostic criteria and treatment principles (fifth revised edition) for evaluation) K. 60 years old ≤ age ≤ 65 years old Exclusion Criteria: Have used other investigational drugs or are participating in other clinical trials within 4 weeks before enrollment; Currently combined with any kind of fungal infection; Allergic to study drugs; Joint transplantation; Women who are pregnant, preparing to become pregnant or breast-feeding; The investigator thinks that it is not suitable to use the test drug.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micafungin Preventing Group<br> | Drug: Micafungin Sodium 50 MG Injection<br>* Give Micafungin 150 mg/d within 24 hours after liver transplantation.<br>|
| Active Comparator: Others Preventing Group<br> | Drug: Caspofungin Acetate<br>* Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-transplant infections | Frequency of clinically or microbiologically documented infection after transplantation. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Micafungin, Invasive Mycosis, Prevention