Back to resultsA Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
Primary Purpose
Candidemia, Candidiasis
Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Micafungin
Sponsored by
About this trial
This is an interventional treatment trial for Candidemia focused on measuring Micafungin, candidiasis, candidemia, Open-label design
Eligibility Criteria
Inclusion Criteria:
- The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
- The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
- Risk factor (s) of infection
- Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
- Two or more positive sputum culture for Candida
Exclusion Criteria:
- Patient received any other antifungal drug within 1 month prior to enrollment.
- HIV positive patient
- Patients with organ transplant
- Patients with agranulocytosis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Intravenous (IV)
Outcomes
Primary Outcome Measures
Overall success rate
success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)
Secondary Outcome Measures
Safety assessed by the incidence of adverse events
Full Information
NCT ID
NCT01982071
First Posted
November 6, 2013
Last Updated
December 18, 2018
Sponsor
Astellas Pharma China, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01982071
Brief Title
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
Official Title
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Due to administrative reasons
Study Start Date
September 26, 2013 (Actual)
Primary Completion Date
August 28, 2015 (Actual)
Study Completion Date
August 28, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma China, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia, Candidiasis
Keywords
Micafungin, candidiasis, candidemia, Open-label design
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Micafungin
Intervention Description
Intravenous (IV)
Primary Outcome Measure Information:
Title
Overall success rate
Description
success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Safety assessed by the incidence of adverse events
Time Frame
up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
Risk factor (s) of infection
Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
Two or more positive sputum culture for Candida
Exclusion Criteria:
Patient received any other antifungal drug within 1 month prior to enrollment.
HIV positive patient
Patients with organ transplant
Patients with agranulocytosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Principal Investigator
Facility Information:
City
Beijing
Country
China
City
Changsha
Country
China
City
Chengdu
Country
China
City
Fuzhou
Country
China
City
Guangzhou
Country
China
City
Harbin
Country
China
City
Hengyang
Country
China
City
Jinan
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
City
Shaoyang
Country
China
City
Shenyang
Country
China
City
Tianjin
Country
China
City
Xi'an
Country
China
City
Xiamen
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=172
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
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