A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

Invasive Fungal Infections Clinical Trial

Official title:

A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02678598
• Other study ID #: 9463-MA-3003
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: February 5, 2016
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2555
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infection
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Micafungin
Intravenous

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall success rate	Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%	Up to 12 months	No
Secondary	Overall incidence and severity of adverse events		Up to 12 months	No
Secondary	Overall incidence and severity of adverse drug reactions		Up to 12 months	No