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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017787
Receipt No. R000020575
Scientific Title Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Date of disclosure of the study information 2015/07/01
Last modified on 2015/12/03

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Basic information
Public title Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Acronym Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Scientific Title Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Scientific Title:Acronym Mycoplasma pneumoniae Antigen Detection Kit Evaluation Study
Region
Japan

Condition
Condition Mycoplasma peumoniae infection
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of Mycoplasma pneumoniae detection kit for the diagnosis performance using a pharynx wiping liquid obtained from patients with respiratory infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity), and an overall agreement rate between Mycoplasma pneumoniae antigen detection kit and quantitative polymerase chain reaction (q-PCR).
Key secondary outcomes Analysis of a positive agreement rate (sensitivity), a negative agreement rate (specificity), and an overall agreement rate between the following conventional test and q-PCR.
LAMP
Serological test

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) A patient over 15 years old with respiratory infection symptom.
2) A patient or legally authorized representative must provide written informed consent.
Key exclusion criteria 1) Specimens are not obtained from a patient.
2) A patient who had been enrolled this study.
3) An investigator determines that a patient is unsuitable for this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Izumikawa
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Unit of Molecular Microbiology and Immunology Department of Infectious Disease
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7731
Email koizumik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Izumikawa
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Unit of Molecular Microbiology and Immunology Department of Infectious Disease
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7731
Homepage URL
Email koizumik@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2015 Year 07 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
2015 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective study.

Management information
Registered date
2015 Year 06 Month 03 Day
Last modified on
2015 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020575

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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