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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04738955
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Shandong Provincial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease Drug: Micafungin Sodium Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The patients will be randomized either low dose group or high dose group
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High dose group
micafungin sodium ≥ 200, ≤ 300 mg/time, once a day, intravenous drip
 Drug: Micafungin Sodium
micafungin sodium ≥ 100, <200mg/time, once a day, intravenous drip. Low dose group


Outcome Measures
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Primary Outcome Measures :
  1. clinical efficacy [ Time Frame: 14 days ]
    Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin


Secondary Outcome Measures :
  1. Safety assessed by lab-test and adverse events [ Time Frame: 30 days ]
    Incidence of adverse reactions in different dose groups of micafungin

  2. Survival rate [ Time Frame: 30 days ]
    IFD-related mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04738955


Contacts
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Contact: xin wang, MD, PHD 86-531-68778331 xinw007@126.com
Contact: changqing zhen, MD 86-531-68778331 zcq1521@163.com

Locations
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China, Shandong
Department of Hematology, Provincial Hospital Affiliated to Shandong University Recruiting
Jinan, Shandong, China, 250021
Contact: changqing zhen, MD    86-531-68778331    zcq1521@163.com   
Sponsors and Collaborators
Shandong Provincial Hospital
Investigators
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Study Chair: xin wang, MD, PHD Shandong Provincial Hospital
More Information
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Responsible Party: Wang Xin, Director of Department of Hematology, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT04738955    
Other Study ID Numbers: ShandongPH12
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wang Xin, Shandong Provincial Hospital:
hematological tumors
Invasive Fungal Disease
Additional relevant MeSH terms:
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Mycoses
Invasive Fungal Infections
Hematologic Neoplasms
Neoplasms
Infections
Bacterial Infections and Mycoses
 Neoplasms by Site
Hematologic Diseases
Micafungin
Antifungal Agents
Anti-Infective Agents