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

Primary Purpose

Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Micafungin Sodium

About this trial

This is an interventional treatment trial for Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease focused on measuring hematological tumors, Invasive Fungal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old, male or female
Patients with hematological tumors
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.
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
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:

The patient is being treated with an antifungal drug
People who are known or suspected to be allergic to echinocandins
The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis.
Existing drug sensitivity results suggest that patients resistant to micafungin
Severe chronic liver disease with Child-Pugh grade C
Fever caused by tumor
Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective
Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not.
Patients who were not considered suitable for the research

Sites / Locations

Department of Hematology, Provincial Hospital Affiliated to Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High dose group

Arm Description

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

Outcomes

Primary Outcome Measures

clinical efficacy

Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin

Secondary Outcome Measures

Safety assessed by lab-test and adverse events

Incidence of adverse reactions in different dose groups of micafungin

Survival rate

IFD-related mortality

Full Information

NCT ID

NCT04738955

First Posted

January 16, 2021

Last Updated

February 1, 2021

Sponsor

Shandong Provincial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04738955

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Provincial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease

Keywords

hematological tumors, Invasive Fungal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High dose group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Micafungin Sodium

Intervention Description

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

Primary Outcome Measure Information:

Title

clinical efficacy

Description

Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Safety assessed by lab-test and adverse events

Description

Incidence of adverse reactions in different dose groups of micafungin

Time Frame

30 days

Title

Survival rate

Description

IFD-related mortality

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years old, male or female Patients with hematological tumors 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. 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 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: The patient is being treated with an antifungal drug People who are known or suspected to be allergic to echinocandins The infection is suspected to be caused by parasites, viruses or Mycobacterium tuberculosis. Existing drug sensitivity results suggest that patients resistant to micafungin Severe chronic liver disease with Child-Pugh grade C Fever caused by tumor Micafungin in the Treatment of Fungal Infections Caused by Cryptococcus, Zygomycetes and Trichospora that Are Ineffective Removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not. Patients who were not considered suitable for the research

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

xin wang, MD, PHD

Phone

86-531-68778331

xinw007@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

changqing zhen, MD

Phone

86-531-68778331

zcq1521@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xin wang, MD, PHD

Organizational Affiliation

Shandong Provincial Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Hematology, Provincial Hospital Affiliated to Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

changqing zhen, MD

Phone

86-531-68778331

zcq1521@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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