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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034777
Receipt No. R000039659
Scientific Title Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Date of disclosure of the study information 2020/12/01
Last modified on 2021/03/12

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Basic information
Public title Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Acronym Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Scientific Title Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Scientific Title:Acronym Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Region
Japan

Condition
Condition respiratory syncytial virus (RSV) infection, adenovirus infection
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of rapid diagnostic test for RS virus and adenovirus infection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity, specificity and detection limit of rapid diagnostic test for RS virus and adenovirus infection
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver Other
Interventions/Control_1 Sample collection, assay with test kit
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 Patients that visit the medical institution during this study, and include the following conditions:
1) Patients with suspected RSV or Adeno virus infection based on symptoms.
2) Patients who agree to participate in this study.
Key exclusion criteria 1) Patients who are difficult to obtain clinical samples from.
2) For any reason other than above, patients who were determined by doctor as being unfit to participate in this study.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Keiko
Middle name
Last name Mitamura
Organization Eiju General Hospital
Division name Division for infection control
Zip code 110-8645
Address 2-23-16 Higashi-ueno, Taito-ku Tokyo 110-8645, Japan
TEL 03-3833-8381
Email mitamurakeiko77@gmail.com

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Maehara
Organization Sekisui Medical Co., Ltd.
Division name Research & Development
Zip code 103-0027
Address 1-3 Nihonbashi 2-chome, Chuo-ku Tokyo 103-0027, Japan
TEL 03-3272-0677
Homepage URL
Email yuta.maehara@sekisui.com

Sponsor
Institute Sekisui Medical Co., Ltd.
Institute
Department

Funding Source
Organization Sekisui Medical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Zama Children's Clinic, Ichikawa Children's Clinic, Abe Children's Clinic, Kobayashi International Clinic, Jichi Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization -
Address -
Tel -
Email -

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 座間小児科診療所(神奈川県)、市川こどもクリニック(神奈川県)、あべこどもクリニック(神奈川県)、小林国際クリニック(神奈川県)、自治医科大学(栃木県)、永寿総合病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 12 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 Completed
Date of protocol fixation
2018 Year 10 Month 15 Day
Date of IRB
2018 Year 10 Month 09 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
2019 Year 09 Month 15 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 10 Month 04 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2021 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039659

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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