UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011388
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Last 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
Email ohge@hiroshima-u.ac.up

Public contact
1st 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
Email ohge@hiroshima-u.ac.jp

Sponsor
Institute Department of infectious disease, Hiroshima University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011692


Contact us.