A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
1 other identifier
observational
2,555
1 country
17
Brief Summary
The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
February 10, 2016
CompletedFebruary 10, 2016
February 1, 2016
5 months
February 2, 2016
February 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall success rate
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%
Up to 12 months
Secondary Outcomes (2)
Overall incidence and severity of adverse events
Up to 12 months
Overall incidence and severity of adverse drug reactions
Up to 12 months
Study Arms (1)
Micafungin group
Interventions
Eligibility Criteria
The hospitalized patients who received intravenous micafungin for treatment according to the clinical judgment of the treating physician before the end of April 2015
You may qualify if:
- Patients who received Micafungin as empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy
- Patients received Micafungin treatment at least 1 dose
You may not qualify if:
- Patients received Micafungin treatment combined with other antifungal drugs at the same time
- Neither efficacy or safety can be evaluated because of missing data, confused record
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Beijing, China
Unknown Facility
Changchun, China
Unknown Facility
Chengdu, China
Unknown Facility
Chongqing, China
Unknown Facility
Fuzhou, China
Unknown Facility
Guangzhou, China
Unknown Facility
Guizhou, China
Unknown Facility
Haikou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Harbin, China
Unknown Facility
Hengyang, China
Unknown Facility
Langfang, China
Unknown Facility
Shanghai, China
Unknown Facility
Shijiazhuang, China
Unknown Facility
Wuhan, China
Unknown Facility
Xiamen, China
Unknown Facility
Zhengzhou, China
Related Publications (1)
Zheng X, Huang X, Luo J, Li J, Li W, Liu Q, Niu T, Wang X, Zhou J, Zhang X, Hu J, Liu K. Effectiveness and Tolerability of Micafungin in Chinese Patients with Invasive Fungal Infections: A Retrospective, Multicenter Study. Adv Ther. 2018 Sep;35(9):1400-1410. doi: 10.1007/s12325-018-0762-5. Epub 2018 Aug 13.
PMID: 30105657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma China, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2016
First Posted
February 10, 2016
Study Start
March 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
February 10, 2016
Record last verified: 2016-02