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

Phase 4

Not yet recruiting

• Conditions: Liver Transplantation
• Interventions: Drug: Micafungin Sodium 50 MG Injection; Drug: Caspofungin Acetate

• Registration Number: NCT04728971
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-13
• Last Update Posted: 2022-08-16
• Study Start: 2022-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micafungin Preventing Group	Micafungin Sodium 50 MG Injection	-
Others Preventing Group	Caspofungin Acetate	-

Primary Outcome Measures

Name	Time	Method
Post-transplant infections	90 days	Frequency of clinically or microbiologically documented infection after transplantation.