UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025746
Receipt number 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 10:54:27

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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 or person

Institute

MIZUHO MEDY Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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