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

NCT04728971 — Phase 4, Unknown, 200 participants, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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RegistryNCT04728971
StatusUnknown
PhasePhase 4
Study typeInterventional; non randomized, single group, masking: none, prevention
Enrollment200 (Estimated)
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Other)
ConditionsLiver Transplantation
InterventionsMicafungin Sodium 50 MG Injection, Caspofungin Acetate (Drug)
Datesstart 2022-10-01 (estimated), primary completion 2025-10-01 (estimated), completion 2026-02-01 (estimated), first posted 2021-01-28, last updated 2022-08-16

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-Summary

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

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+Arms and interventions

ArmTypeInterventionsDescription
Micafungin Preventing GroupExperimentalDrug: Micafungin Sodium 50 MG Injection
Others Preventing GroupActive comparatorDrug: Caspofungin Acetate
  • Micafungin Sodium 50 MG Injection (Drug): Give Micafungin 150 mg/d within 24 hours after liver transplantation.
  • Caspofungin Acetate (Drug): Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.

+Outcome measures

Primary outcomes

  • Post-transplant infections [90 days]: Frequency of clinically or microbiologically documented infection after transplantation.

+Eligibility

Sex: All, ages: 60 Years to 65 Years

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.

My Notes