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

NCT ID: NCT04728971

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-02-01

Brief Summary

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

Conditions

Liver Transplantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Micafungin Preventing Group

Group Type: EXPERIMENTAL

Micafungin Sodium 50 MG Injection

Intervention Type: DRUG

Give Micafungin 150 mg/d within 24 hours after liver transplantation.

Others Preventing Group

Group Type: ACTIVE_COMPARATOR

Caspofungin Acetate

Intervention Type: DRUG

Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.

Interventions

Micafungin Sodium 50 MG Injection

Give Micafungin 150 mg/d within 24 hours after liver transplantation.

Intervention Type: DRUG

Caspofungin Acetate

Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lin Zhong

Director of Hepatobiliary and Pancreatic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SHLTQC-4

Identifier Type: -

Identifier Source: org_study_id