UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016935 |
|---|---|
| Receipt number | R000019659 |
| Scientific Title | Molecular diagnosis for bacterial or fungal infection of the eye using Polymerase Chain Reaction (PCR) |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/10/10 16:10:11 |
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Basic information
Public title
Molecular diagnosis for bacterial or fungal infection of the eye using Polymerase Chain Reaction (PCR)
Acronym
Rapid diagnosis for ocular infection using PCR
Scientific Title
Molecular diagnosis for bacterial or fungal infection of the eye using Polymerase Chain Reaction (PCR)
Scientific Title:Acronym
Rapid diagnosis for ocular infection using PCR
Region
| Japan |
Condition
Condition
Endophthalmitis suspected for bacterial or fungal infection.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate diagnostic efficacy of real time PCR for bacterial or fungal infection of the eye
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of microbial DNA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluate bacterial or fungal DNA amount using real-time PCR.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Endophthalmitis patient suspected for bacterial or fungal infection
Key exclusion criteria
Patients who did not give informed consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MIYAZAKI Dai |
Organization
Tottori university
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6617
dm@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIYAZAKI Dai |
Organization
Tottori university
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6617
Homepage URL
dm@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university Division of Ophthalmology and Visual Science
Institute
Department
Personal name
Funding Source
Organization
Tottori university Division of Ophthalmology and Visual Science
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | 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
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019659
