UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032625 |
|---|---|
| Receipt number | R000036594 |
| Scientific Title | Study on rapid diagnostic reagent for Mycoplasma pneumoniae antigen detection reagent |
| Date of disclosure of the study information | 2019/11/30 |
| Last modified on | 2020/11/17 09:14:38 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036594
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
