Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678598
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )

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
Invasive Fungal Infections Drug: Micafungin

Layout table for study information
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 : March 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Overall success rate [ Time Frame: 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 [ Time Frame: Up to 12 months ]
  2. Overall incidence and severity of adverse drug reactions [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678598


Locations
Layout table for location information
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
Sponsors and Collaborators
Astellas Pharma China, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma China, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Astellas Pharma China, Inc.
ClinicalTrials.gov Identifier: NCT02678598    
Other Study ID Numbers: 9463-MA-3003
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma China, Inc. ):
Micafungin
Candida
Aspergillosis
Antifungal
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections
Micafungin
Antifungal Agents
Anti-Infective Agents