NCT04738955

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease

Interventions

Type	Name	Description
DRUG	Micafungin Sodium	micafungin sodium ≥ 100, \<200mg/time, once a day, intravenous drip. Low dose group

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-01-01
• Completion: 2023-10-01
• First posted: 2021-02-04
• Last updated: 2021-02-04

Locations

1 site across 1 country: China