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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04728971

Enrollment

200

Registered

2021-01-28

Start date

2022-10-01

Completion date

2026-02-01

Last updated

2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Micafungin, Invasive Mycosis, Prevention

Brief summary

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

Interventions

DRUGMicafungin Sodium 50 MG Injection

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

DRUGCaspofungin Acetate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026