Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection in Hematological Tumors

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    230
  • sponsor
    Shandong Provincial Hospital
Updated on 15 February 2021

Summary

This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.

Description

This is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. Researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. During the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.All subjects were monitored for efficacy and safety according to the visit plan during the research.

Details
Condition Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
Treatment Micafungin Sodium
Clinical Study IdentifierNCT04738955
SponsorShandong Provincial Hospital
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old, male or female
Patients with hematological tumors
Neutropenia: The absolute neutrophils count (ANC) in peripheral blood was 0.5109/L or was expected to be ANC<0.5109/L 48 hours later
Fever: single measurement of oral temperature 38.3 (axillary temperature 38.0) or oral temperature 38.0 (axillary temperature 37.7) lasts for more than 1h
Patients with high risk factors of IFD (Invasive Fungal Disease), such as patients treated with allo-HSCT, patients with acute leukemia (including MDS) undergoing primary induction or rescue chemotherapy, patients with expected granulocytosis lasting more than 10 days, patients with severe granulocytosis or patients with severe aplastic anemia receiving antithymic globulin (ATG) therapy or HSCT therapy, etc

Exclusion Criteria

The patient is being treated with an antifungal drug
People who are known or suspected to be allergic to echinocandins
The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis
Existing drug sensitivity results suggest that patients resistant to micafungin
Severe chronic liver disease with Child-Pugh grade C
Fever caused by tumor
Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective
Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not
Patients who were not considered suitable for the research
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