Study Stopped
Due to administrative reasons
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)
1 other identifier
interventional
59
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2013
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2013
CompletedFirst Submitted
Initial submission to the registry
November 6, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2015
CompletedNovember 20, 2024
November 1, 2024
1.9 years
November 6, 2013
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall success rate
success rate is calculated as (number of success patients/number of patients for efficacy evaluation Ă— 100% at end of treatment)
up to 8 weeks
Secondary Outcomes (1)
Safety assessed by the incidence of adverse events
up to 10 weeks
Study Arms (1)
Treatment group
EXPERIMENTALIntravenous (IV)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient received any other antifungal drug within 1 month prior to enrollment.
- HIV positive patient
- Patients with organ transplant
- Patients with agranulocytosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Beijing, China
Unknown Facility
Changsha, China
Unknown Facility
Chengdu, China
Unknown Facility
Fuzhou, China
Unknown Facility
Guangzhou, China
Unknown Facility
Harbin, China
Unknown Facility
Hengyang, China
Unknown Facility
Jinan, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, China
Unknown Facility
Shaoyang, China
Unknown Facility
Shenyang, China
Unknown Facility
Tianjin, China
Unknown Facility
Xi'an, China
Unknown Facility
Xiamen, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2013
First Posted
November 13, 2013
Study Start
September 26, 2013
Primary Completion
August 28, 2015
Study Completion
August 28, 2015
Last Updated
November 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.