UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011388 |
|---|---|
| Receipt number | R000011692 |
| Scientific Title | Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine |
| Date of disclosure of the study information | 2013/08/07 |
| Last modified on | 2014/06/17 15:01:27 |
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Basic information
Public title
Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine
Acronym
Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine
Scientific Title
Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine
Scientific Title:Acronym
Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine
Region
| Japan |
Condition
Condition
Patients undergoing gastroenterological surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of micafungin in patients with a proven, probable, or possible invasive fungal infection in surgery and intensive-care medicine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The efficacy of micafungin in patients with a proven or probable invasive fungal infection is evaluated on the 14th day (initial assessment) and at the end of dosing (final assessment).
2. The efficacy of micafungin in patients with a possible invasive fungal infection is evaluated on the 7th day (initial assessment) and at the end of dosing (final assessment).
Key secondary outcomes
1. Persistence rate of micafungin administration
2. Adverse event during micafungin administration and follow-up
3. Mortality rate during micafungin administration
4.Susceptibility of isolated Candida spp.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Patients with a proven or probable invasive fungal infections
Micafungin, 150 mg (dissolved in saline) per day, is administered as a more than 1-hour infusion. Initial assessment is done on the 14th day, and the end or continuance of administration is decided. If the effect, based on a patient's symptoms and the physical examination findings, is insufficient within 14 days, the dose increase or change to other drug at a physician's discretion is permitted. Micafungin (300 mg) is administered to the patients with funduscopic finding.
Interventions/Control_2
2. Patients with a possible invasive fungal infections
Micafungin, 100 mg (dissolved in saline) per day, is administered as a more than 1-hour infusion. Initial assessment is done on the 7th day, and the end or continuance of administration is decided. If the effect, based on a patient's symptoms and the physical examination findings, is insufficient within 7 days, the dose increase or change to other drug at a physician's discretion is permitted.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with a diagnosis of invasive fungal infections among febrile patients unresponsive to broad-spectrum antibiotics with several risk factors.
1.High APACHIII score
2.ICU length of stay: more than 7 days
3.Mechanical ventilator: more than 48 hours
4.Patients with renal dysfunction or on dialysis
5.Severe acute pancreatitis, diabetes
6.Perforation of the upper gastrointestinal tract
7.IVH indwelling line, high-calorie infusion
8.Steroid administration: more than 3 weeks
9.Within 30 days after the last immunosuppressant therapy
10.Other serious disease complication
2.Patients with a proven or probable invasive fungal infections
Patients for whom Candida species are detected at blood, tip of a central venous catheter, puncture of abscess or sterile site, or for whom fungal endophthalmitis is observed in funduscopic finding.
3.Patients with a possible invasive fungal infections
Patients with a possible invasive fungal infections for whom beta-D-glucan is positive or the colonization Candida species is detected in surveillance culture.
Key exclusion criteria
1. Patients with a history of drug allergy against micafungin.
2. Patients with severe hepatic dysfunction.
(bilirubin concentrations three times or ALT or AST five times the upper limit of the normal reference range)
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Ohge |
Organization
Hiroshima University Hospital
Graduate School of Biomedical Sciences, Hiroshima University.
Division name
Department of infectious disease
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-1613
ohge@hiroshima-u.ac.up
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Ohge |
Organization
Hiroshima University Hospital
Division name
Department of infectious disease
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-1613
Homepage URL
ohge@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of infectious disease, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）
国家公務員共済組合連合会 広島記念病院（広島県）
市立三次中央病院（広島県）
国家公務員共済組合連合会 呉共済病院（広島県）
マツダ病院（広島県）
広島県立広島病院（広島県）
県立広島病院、広島市立安佐市民病院（広島県）
JA広島厚生連 尾道総合病院（広島県）
特定医療法人あかね会 土谷総合病院（広島県）
広島市立広島市民病院（広島県）
独立行政法人国立病院機構 呉医療センター（広島県）
独立行政法人労働者健康福祉機構 中国労災病院（広島県）
広島県厚生農業協同組合連合会 廣島総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 06 | Day |
Last modified on
| 2014 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011692
