UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039536 |
|---|---|
| Receipt number | R000044903 |
| Scientific Title | Comprehensive rapid PCR diagnosis for intractable viral, bacterial and fungal eye infections. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/03/01 18:17:53 |
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Basic information
Public title
Comprehensive rapid PCR diagnosis for intractable viral, bacterial and fungal eye infections.
Acronym
Comprehensive rapid PCR diagnosis for intractable eye infections.
Scientific Title
Comprehensive rapid PCR diagnosis for intractable viral, bacterial and fungal eye infections.
Scientific Title:Acronym
Comprehensive rapid PCR diagnosis for intractable eye infections.
Region
| Japan |
Condition
Condition
Intractable eye infection
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using qualitative multiplex PCR to screen for pathogens in patients with suspected refractory viral, bacterial, and fungal eye infections, identify pathogens and determine therapeutic efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of pathogens from collected samples
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
| 13 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with suspected intractable eye infection.
Key exclusion criteria
Patients who do not agree to sample collection.
Patients judged inappropriate by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Shoji |
Organization
Kitasato University School of Medicine
Division name
Department of Ophthalmology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
042-778-8111
nshoji@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Satoh |
Organization
Kitasato University School of Medicine
Division name
Department of Ophthalmology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
nosatou-ktz@umin.org
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kitasato University School of Medicine and Hospital Clinical Research Review Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, Japan
Tel
042-778-8111
rinri-n@kitasato-u.ac.jp
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
| 2020 | 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
| 2020 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Background factors
Gender, age, medical history, medical history, family history, complications
2) Medication
Investigate the drug name, dosage / method, administration period, and medication status of all drugs administered at all consultations, including treatment and concomitant medications.
3) Observation and inspection items for efficacy and safety
Perform a general ophthalmic examination (visual acuity, intraocular pressure, anterior segment, fundus examination, etc.) at every visit
4) Adverse events
At any time, record any adverse events that occur.
Management information
Registered date
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
