Clinical trial NCT04738955: Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection in Hematological Tumors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
Keywords: hematological tumors
Invasive Fungal Disease
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-04
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The patients will be randomized either low dose group or high dose group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical efficacy
timeFrame: 14 days
Secondary outcomes:
measure: Safety assessed by lab-test and adverse events
timeFrame: 30 days
measure: Survival rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Hematology, Provincial Hospital Affiliated to Shandong University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: xin wang, MD, PHD
role: STUDY_CHAIR
References: