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

February 5, 2016 updated by: Astellas Pharma China, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2555

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Changchun, China
      • Chengdu, China
      • Chongqing, China
      • Fuzhou, China
      • Guangzhou, China
      • Guizhou, China
      • Haikou, China
      • Hangzhou, China
      • Harbin, China
      • Hengyang, China
      • Langfang, China
      • Shanghai, China
      • Shijiazhuang, China
      • Wuhan, China
      • Xiamen, China
      • Zhengzhou, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The hospitalized patients who received intravenous micafungin for treatment according to the clinical judgment of the treating physician before the end of April 2015

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Micafungin group
Drug: Micafungin
Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall success rate
Time Frame: Up to 12 months
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall incidence and severity of adverse events
Time Frame: Up to 12 months
Up to 12 months
Overall incidence and severity of adverse drug reactions
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma China, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9463-MA-3003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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