Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease Clinical Trial
Official title:
Prospective, Observational and Cohort Clinical Research on Clinical Efficacy and Safety of Different Doses of Micafungin Sodium for Injection in Prevention and Treatment of Fungal Infection in Patients With Hematological Tumors
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.
| Status | Recruiting |
| Enrollment | 230 |
| Est. completion date | October 1, 2023 |
| Est. primary completion date | January 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Age = 18 years old, male or female 2. Patients with hematological tumors 3. 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. 4. 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 5. 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: 1. The patient is being treated with an antifungal drug 2. People who are known or suspected to be allergic to echinocandins 3. The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis. 4. Existing drug sensitivity results suggest that patients resistant to micafungin 5. Severe chronic liver disease with Child-Pugh grade C 6. Fever caused by tumor 7. Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective 8. Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not. 9. Patients who were not considered suitable for the research |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Hematology, Provincial Hospital Affiliated to Shandong University | Jinan | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| Shandong Provincial Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical efficacy | Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin | 14 days | |
| Secondary | Safety assessed by lab-test and adverse events | Incidence of adverse reactions in different dose groups of micafungin | 30 days | |
| Secondary | Survival rate | IFD-related mortality | 30 days |