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

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04728971
Collaborator
(none)
200
Enrollment
2
Arms
40
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Micafungin Sodium 50 MG Injection
  • Drug: Caspofungin Acetate
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Post-transplant infections [90 days]

    Frequency of clinically or microbiologically documented infection after transplantation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lin Zhong, Director of Hepatobiliary and Pancreatic Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04728971
Other Study ID Numbers:
  • SHLTQC-4
First Posted:
Jan 28, 2021
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lin Zhong, Director of Hepatobiliary and Pancreatic Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Micafungin
Invasive Mycosis
Prevention
Additional relevant MeSH terms:
Mycoses
Invasive Fungal Infections
Caspofungin
Micafungin

Study Results

No Results Posted as of Aug 16, 2022