UMIN-CTR Clinical Trial

Basic information
Public title	Study on rapid diagnostic reagent for Mycoplasma pneumoniae antigen detection reagent
Acronym	Study on rapid diagnostic reagent for Mycoplasma pneumoniae antigen detection reagent
Scientific Title	Study on rapid diagnostic reagent for Mycoplasma pneumoniae antigen detection reagent
Scientific Title:Acronym	Study on rapid diagnostic reagent for Mycoplasma pneumoniae antigen detection reagent
Region	Japan

Condition
Condition	Mycoplasma pneumoniae infectious disease
Classification by specialty	Pneumology Infectious disease Hepato-biliary-pancreatic surgery Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical evaluation of usefulness of naso-pharyngeal aspiration specimens in Mycoplasma pneumoniae antigen rapid diagnosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlative evaluation with results obt ained by PCR assay.
Key secondary outcomes	Correlative evaluation of Mycoplasma pneumoniae antigen rapid diagnostic test results in throat swab and nasopharyngeal aspiration specimen.

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 testing 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	Public benefit foundation corporation Life Extension Laboratory attached Eiju general hospital
Division name	Pediatrics
Zip code
Address	23-16, 2 Chome, Higashi Ueno, Taito Ward, Tokyo 110-8645
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）、市川こどもクリニック（神奈川県）、株式会社ミズホメディー（佐賀県）

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 30 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 02 Month 27 Day
Date of IRB	2018 Year 03 Month 16 Day
Anticipated trial start date	2018 Year 04 Month 25 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 03 Month 09 Day

Other

Other related information

Examination design: Evaluate the results of Mycoplasma pneumoniae antigen test results using naso-pharyngeal aspiration specimen and throat swab based on the Mycoplasma pneumoniae gene test result by PCR. How to recruit subjects: Everyone who meets the selection criteria and does not meet exclusion criteria in patients who visit Institutions during the period from the start of the examination to December 2019. Items to be measured: 1)Mycoplasma pneumoniae antigen test using the naso-pharyngeal aspiration specimen. 2)Mycoplasma pneumoniae antigen test using the throat swab. 3)Mycoplasma pneumoniae gene test by PCR.

Management information
Registered date	2018 Year 05 Month 17 Day
Last modified on	2020 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036594