Status:
NOT_YET_RECRUITING
To Evaluate the Efficacy and Safety of Micafungin in Preventing Invasive Mycosis After Liver Transplantation
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Liver Transplantation
Eligibility:
All Genders
60-65 years
Phase:
PHASE4
Brief Summary
To evaluate the clinical success rate of micafungin in preventing invasive mycosis after liver transplantation.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04728971
Start Date
October 1 2022
End Date
February 1 2026
Last Update
August 16 2022
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