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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease
• Intervention / Treatment: Drug: Micafungin Sodium

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 Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Department of Hematology, Provincial Hospital Affiliated to Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical efficacy	Breakthrough incidence of Invasive Fungal Infection (IFI), during prophylaxis use of micafungin	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by lab-test and adverse events	Incidence of adverse reactions in different dose groups of micafungin	30 days
Survival rate	IFD-related mortality	30 days

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): October 1, 2023

Study Registration Dates

• First Submitted: January 16, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: hematological tumors; Invasive Fungal Disease
• Additional Relevant MeSH Terms: Infections; Neoplasms; Neoplasms by Site; Hematologic Diseases; Bacterial Infections and Mycoses; Hematologic Neoplasms; Mycoses; Invasive Fungal Infections; Anti-Infective Agents; Antifungal Agents; Micafungin
• Other Study ID Numbers: ShandongPH12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No