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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Caspofungin Acetate; Drug: Micafungin Sodium 50 MG Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04728971

SHLTQC-4

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 60 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sign the informed consent form voluntarily;
2. 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

1. Have used other investigational drugs or are participating in other clinical trials within 4 weeks before enrollment;
2. Currently combined with any kind of fungal infection;
3. Allergic to study drugs;
4. Joint transplantation;
5. Women who are pregnant, preparing to become pregnant or breast-feeding;
6. The investigator thinks that it is not suitable to use the test drug.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Micafungin Preventing Group

Experimental group

Treatment:

Drug: Micafungin Sodium 50 MG Injection

Others Preventing Group

Active Comparator group

Treatment:

Drug: Caspofungin Acetate