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

• Sponsor: Astellas Pharma China, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02678598
• Collaborator: (none)
• Enrollment: 2,555
• Locations: 17
• Duration (Months): 5
• Patients Per Site: 150.3
• Patients Per Site Per Month: 29.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Drug: Micafungin

Study Design

• Study Type: Observational
• Actual Enrollment: 2555 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Micafungin group	Drug: Micafungin; Intravenous

Outcome Measures

Primary Outcome Measures

1. Overall success rate [Up to 12 months]

   Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%

Secondary Outcome Measures

1. Overall incidence and severity of adverse events [Up to 12 months]

2. Overall incidence and severity of adverse drug reactions [Up to 12 months]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Beijing		China
2		Changchun		China
3		Chengdu		China
4		Chongqing		China
5		Fuzhou		China
6		Guangzhou		China
7		Guizhou		China
8		Haikou		China
9		Hangzhou		China
10		Harbin		China
11		Hengyang		China
12		Langfang		China
13		Shanghai		China
14		Shijiazhuang		China
15		Wuhan		China
16		Xiamen		China
17		Zhengzhou		China

Sponsors and Collaborators

• Astellas Pharma China, Inc.

Investigators

• Study Director: Medical Director, Astellas Pharma China, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astellas Pharma China, Inc.
• ClinicalTrials.gov Identifier: NCT02678598
• Other Study ID Numbers: 9463-MA-3003
• First Posted: Feb 10, 2016
• Last Update Posted: Feb 10, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Astellas Pharma China, Inc.: Micafungin; Candida; Aspergillosis; Antifungal
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Micafungin

Study Results

No Results Posted as of Feb 10, 2016