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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The patients will be randomized either low dose group or high dose group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High dose group

micafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip

Group Type EXPERIMENTAL

Micafungin Sodium

Intervention Type DRUG

micafungin sodium ≥ 100, \<200mg/time, once a day, intravenous drip. Low dose group

Interventions

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Micafungin Sodium

micafungin sodium ≥ 100, \<200mg/time, once a day, intravenous drip. Low dose group

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No