Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
Conditions
Keywords
hematological tumors, Invasive Fungal Disease
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 patients with hematological tumors.
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 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.
Interventions
micafungin sodium ≥ 100, \<200mg/time, once a day, intravenous drip. Low dose group
Sponsors
Shandong Provincial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patients will be randomized either low dose group or high dose group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical efficacy | 14 days | Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by lab-test and adverse events | 30 days | Incidence of adverse reactions in different dose groups of micafungin |
| Survival rate | 30 days | IFD-related mortality |
Countries
China
Contacts
Primary Contactxin wang, MD, PHD
Backup Contactchangqing zhen, MD
Outcome results
None listed