Status:
UNKNOWN
Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection in Hematological Tumors
Lead Sponsor:
Shandong Provincial Hospital
Conditions:
Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 patien...
Detailed 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 patien...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, male or female
- Patients with hematological tumors
- Neutropenia: The absolute neutrophils count (ANC) in peripheral blood was 0.5×109/L or was expected to be ANC\<0.5×109/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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04738955
Start Date
February 1 2021
End Date
October 1 2023
Last Update
February 4 2021
Active Locations (1)
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1
Department of Hematology, Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, China, 250021