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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025746
Receipt No. R000029364
Scientific Title Clinical evaluation of silver amplification immunochromatography systems for rapid diagnosis of Mycoplasma pneumoniae .
Date of disclosure of the study information 2017/01/31
Last modified on 2018/01/31

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Basic information
Public title Clinical evaluation of silver amplification immunochromatography systems for rapid diagnosis of Mycoplasma pneumoniae .
Acronym Clinical evaluation of silver amplification immunochromatography systems for rapid diagnosis of Mycoplasma pneumoniae .
Scientific Title Clinical evaluation of silver amplification immunochromatography systems for rapid diagnosis of Mycoplasma pneumoniae .
Scientific Title:Acronym Clinical evaluation of silver amplification immunochromatography systems for rapid diagnosis of Mycoplasma pneumoniae .
Region
Japan

Condition
Condition Mycoplasma pneumoniae infectious disease
Classification by specialty
Pneumology Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical evaluation of silver amplification immunochromatography systems for rapid diagnosis of Mycoplasma pneumoniae .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlative evaluation with results obtained by PCR assay.
Key secondary outcomes Correlative evaluation with results obtained by Ribotest Mycoplasma, and a loop-mediated isothermal amplification assay.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patient applicable to following items.
1) The patient with fever and a cough as presenting symptom.
2) Case patient of 1) and require resting the antigen or nucleic acid of Mycoplasma pneumoniae .
3) The patient who has agreed with the participation to this examination.
Key exclusion criteria Irrelevance patient is excluded in the judgement of doctor.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Mitamura
Organization Eiju General Hospital
Division name Department of Pediatrics
Zip code
Address 2-23-16, Higashiueno, Taitou-ku, Tokyo
TEL 03-3833-8381
Email mitamurakeiko77@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Arao
Organization MIZUHO MEDY Co., Ltd.
Division name R&D Planning Dept.
Zip code
Address 5-4 Fujinoki-Machi, Tosu City, Saga 841-0048 Japan
TEL 0942-85-0303
Homepage URL
Email arao@mizuho-m.co.jp

Sponsor
Institute MIZUHO MEDY Co., Ltd.
Institute
Department

Funding Source
Organization MIZUHO MEDY Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) FUJIFILM Corporation

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 永寿総合病院(東京都)、座間小児科(神奈川県)、株式会社ミズホメディー(佐賀)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41598-018-19734-y
Number of participants that the trial has enrolled
Results
The 48th Annual Meeting of the Japanese Society for Pediatric Infectious Diseases.
Jpn J Med Pharm Sci 73(10)
Scientific Reportsvolume 8, Article number: 1430
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
2015 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Doble blind, prospective, cohort study

Management information
Registered date
2017 Year 01 Month 19 Day
Last modified on
2018 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029364

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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