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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplantation
• Intervention / Treatment: Drug: Micafungin Sodium 50 MG Injection; Drug: Caspofungin Acetate

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2025
• Study Completion (Anticipated): February 1, 2026

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Micafungin; Prevention; Invasive Mycosis
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Micafungin; Caspofungin
• Other Study ID Numbers: SHLTQC-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No