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 2021/09/01 13:11:37

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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

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

8140180

Address

7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan

TEL

092801011

Homepage URL


Email

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

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 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

2021 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049676


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name