UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043503 |
|---|---|
| Receipt number | R000049676 |
| Scientific Title | Comprehensive rapid PCR diagnosis for intractable bacterial and fungal ocular infections. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2025/03/05 12:36:38 |
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Basic information
Public title
Comprehensive rapid PCR diagnosis for intractable bacterial and fungal ocular infections.
Acronym
Comprehensive rapid PCR diagnosis for intractable bacterial and fungal ocular infections.
Scientific Title
Comprehensive rapid PCR diagnosis for intractable bacterial and fungal ocular infections.
Scientific Title:Acronym
Comprehensive rapid PCR diagnosis for intractable bacterial and fungal ocular infections.
Region
| Japan |
Condition
Condition
endophthalmitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using multiplex PCR to screen for pathogens in patients with suspected refractory bacterial and fungal ocular infections, identify pathogens and determine therapeutic efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identify the causative pathogens from collected samples
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Single group allocation
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included.
1. Men and women between the ages of 0 and 100
2. Hypopyon, anterior chamber fibrin, vitreous opacity, and/or endophthalmitis with retinal lesions
3. Patients with written consent
Key exclusion criteria
Patients who do not consent to sample collection and patients who the doctor in charge of the study deems inappropriate are excluded.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Uchio |
Organization
Fukuoka University School of Medicine
Division name
Department of Ophthalmology
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092801011
euchio@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tsukahara-Kawamura |
Organization
Fukuoka University School of Medicine
Division name
Department of Ophthalmology
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092801011
Homepage URL
ttsukahara@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University School of Medicine
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
Clinical Research and Ethics Center, Fukuoka University School of Medicine
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Tel
092801011
fumed-ethics@fukuoka-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
| 2021 | 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
| Delay expected |
Results Delay Reason
Due to the small number of patients
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
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049676
