Overview

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

Status:
Recruiting

Trial end date:
2023-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shandong Provincial Hospital

Treatments:

Micafungin

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