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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04728971
• Other study ID #: SHLTQC-4
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: February 1, 2026

Study information

• Verified date: August 2022
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Fungal Infections
• Liver Transplantation
• Mycoses

Intervention

Drug:
• Micafungin Sodium 50 MG Injection
Give Micafungin 150 mg/d within 24 hours after liver transplantation.
• Caspofungin Acetate
Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-transplant infections	Frequency of clinically or microbiologically documented infection after transplantation.	90 days