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

• Sponsor: Shandong Provincial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04738955
• Collaborator: (none)
• Enrollment: 230
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31.9
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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 groupThe 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: Feb 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

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

Primary Outcome Measures

1. clinical efficacy [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 [30 days]

   Incidence of adverse reactions in different dose groups of micafungin

2. Survival rate [30 days]

   IFD-related mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology, Provincial Hospital Affiliated to Shandong University	Jinan	Shandong	China	250021

Sponsors and Collaborators

• Shandong Provincial Hospital

Investigators

• Study Chair: xin wang, MD, PHD, Shandong Provincial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wang Xin, Director of Department of Hematology, Shandong Provincial Hospital
• ClinicalTrials.gov Identifier: NCT04738955
• Other Study ID Numbers: ShandongPH12
• First Posted: Feb 4, 2021
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wang Xin, Director of Department of Hematology, Shandong Provincial Hospital: hematological tumors; Invasive Fungal Disease
• Additional relevant MeSH terms: Mycoses; Invasive Fungal Infections; Hematologic Neoplasms; Micafungin

Study Results

No Results Posted as of Feb 4, 2021