UMIN-CTR Clinical Trial

Basic information
Public title	Comprehensive rapid PCR diagnosis for refractory viral eye infections
Acronym	Comprehensive rapid PCR diagnosis for refractory viral eye infections
Scientific Title	Comprehensive rapid PCR diagnosis for refractory viral eye infections
Scientific Title:Acronym	Comprehensive rapid PCR diagnosis for refractory viral eye infections
Region	Japan

Condition
Condition	corneal endotheliitis, uveitis
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 viral ocular infections, identify pathogens and determine therapeutic efficacy.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identify the causative pathogens
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. Patients with any of the following pathologies a) Unilateral anterior ocular inflammation with symptoms of mutton-fat keratic precipitates or elevated intraocular pressure (Limited to those suspected of having herpetic uveitis or herpetic iritis.) b) Fundus disease with necrotic lesions on the retina (Limited to those suspected of having acute retinal necrosis, cytomegalovirus retinitis, or progressive retinal outer layer necrosis.) 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	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL	092801011
Email	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	814-0180
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL	092801011
Homepage URL
Email	ttsukahara@adm.fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University School of Medicine
Institute
Department

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
Email	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
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	2021 Year 02 Month 16 Day
Date of IRB	2021 Year 02 Month 16 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	2022 Year 03 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049654