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

Primary Purpose

Liver Transplantation

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Micafungin Sodium 50 MG Injection

Caspofungin Acetate

About this trial

This is an interventional prevention trial for Liver Transplantation focused on measuring Micafungin, Invasive Mycosis, Prevention

Eligibility Criteria

60 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sign the informed consent form voluntarily;
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:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Micafungin Preventing Group

Others Preventing Group

Arm Description

Outcomes

Primary Outcome Measures

Post-transplant infections

Frequency of clinically or microbiologically documented infection after transplantation.

Secondary Outcome Measures

Full Information

NCT ID

NCT04728971

First Posted

January 26, 2021

Last Updated

August 13, 2022

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04728971

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2022 (Anticipated)

Primary Completion Date

October 1, 2025 (Anticipated)

Study Completion Date

February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Transplantation

Keywords

Micafungin, Invasive Mycosis, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Micafungin Preventing Group

Arm Type

Experimental

Arm Title

Others Preventing Group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Micafungin Sodium 50 MG Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Caspofungin Acetate

Intervention Description

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

Primary Outcome Measure Information:

Title

Post-transplant infections

Description

Frequency of clinically or microbiologically documented infection after transplantation.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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