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

NCT04738955 | Unknown Phase 4

• 1 other identifier: ShandongPH12
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease

Keywords

hematological tumors; Invasive Fungal Disease

Outcome Measures

Primary Outcomes (1)

• clinical efficacy

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

  14 days

Secondary Outcomes (2)

• Safety assessed by lab-test and adverse events

  30 days

• Survival rate

  30 days

Study Arms (1)

High dose group

EXPERIMENTAL

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

Drug: Micafungin Sodium

Interventions

Micafungin Sodium DRUG

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

High dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Department of Hematology, Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Invasive Fungal Infections

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• xin wang, MD, PHD

  Shandong Provincial Hospital

  STUDY CHAIR

Central Study Contacts

xin wang, MD, PHD

CONTACT

86-531-68778331; xinw007@126.com

changqing zhen, MD

CONTACT

86-531-68778331; zcq1521@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Hematology

Model Details: The patients will be randomized either low dose group or high dose group

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: February 4, 2021
• Study Start: February 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

CN (1)