UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021836 |
|---|---|
| Receipt number | R000025175 |
| Scientific Title | Multicenter prospective observational study for fungal keratitis |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/04/08 13:26:33 |
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Basic information
Public title
Multicenter prospective observational study for fungal keratitis
Acronym
Prospective observational study for fungal keratitis
Scientific Title
Multicenter prospective observational study for fungal keratitis
Scientific Title:Acronym
Prospective observational study for fungal keratitis
Region
| Japan |
Condition
Condition
Fungal keratitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know backgrounds and clinical courses of fungal keratitis patients, and drug sensitivity of pathogenic fungi in Japan for establishing acurate diagnose and adequate therapy of fungal keratitis.
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Isoration rate of fungi and drug sensitivity.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients or proxies agree to entry this study and fungus is detected from patient's scraped cornea with culture.
Key exclusion criteria
1 Patients infected by microorganism other than fungi.
2 Patients affected corneal disease other than fungal keratitis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunji Yokokura |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-1, Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7294
yokokura@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Miyake |
Organization
Japanese Society of Ocular Infection
Division name
Secretariat
Zip code
Address
3-6-302, Mihoga-oka, Ibaraki, Osaka
TEL
072-623-7878
Homepage URL
folia@hcn.zaq.ne.jp
Sponsor or person
Institute
Department of Ophthalmology, Tottori University Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Ocular Infection
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2016 | Year | 04 | Month | 08 | Day |
Last modified on
| 2016 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025175
