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

NCT04728971 | Unknown Phase 4

• 1 other identifier: SHLTQC-4
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Liver Transplantation

Keywords

Micafungin; Invasive Mycosis; Prevention

Outcome Measures

Primary Outcomes (1)

• Post-transplant infections

  Frequency of clinically or microbiologically documented infection after transplantation.

  90 days

Study Arms (2)

Micafungin Preventing Group

EXPERIMENTAL

Drug: Micafungin Sodium 50 MG Injection

Others Preventing Group

ACTIVE COMPARATOR

Drug: Caspofungin Acetate

Interventions

Micafungin Sodium 50 MG Injection DRUG

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

Micafungin Preventing Group

Caspofungin Acetate DRUG

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

Others Preventing Group

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Micafungin; Injections; Caspofungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatobiliary and Pancreatic Surgery

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 28, 2021
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 16, 2022

Record last verified: 2022-08