UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032985 |
|---|---|
| Receipt number | R000037607 |
| Scientific Title | Epidemiological research on Mycoplasma pneumoniae infections and Chlamydophila pneumoniae infections in Japanese children. |
| Date of disclosure of the study information | 2018/06/14 |
| Last modified on | 2020/07/31 18:23:03 |
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Basic information
Public title
Epidemiological research on Mycoplasma pneumoniae infections and Chlamydophila pneumoniae infections in Japanese children.
Acronym
Research on pediatric infections with Mycoplasma pneumoniae and Chlamydophila pneumoniae.
Scientific Title
Epidemiological research on Mycoplasma pneumoniae infections and Chlamydophila pneumoniae infections in Japanese children.
Scientific Title:Acronym
Research on pediatric infections with Mycoplasma pneumoniae and Chlamydophila pneumoniae.
Region
| Japan |
Condition
Condition
Mycoplasma pneumoniae and Chlamydophila pneumoniae infections
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of our research is to reveal the epidemiological feature of Mycoplasma pneumoniae and Chlamidia pneumoniae infections in Japanese Children and investigate the reason of outbreak of Macrolide resistant isolates among these isolates.
Basic objectives2
Others
Basic objectives -Others
The subjects of our research are the isolates of Mycoplasma pneumoniae and Chlamidia pneumoniae originated from Japanese children with Mycoplasma pneumoniae and Chlamidia pneumoniae infections.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in M.pneumoniae and C.pneumoniae infections
Prevalence of Macrolide resistance among isolates.
Key secondary outcomes
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese Children with lower respiratory infections
Key exclusion criteria
The cases we can not get informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Oishi |
Organization
Kawasaki Medical School
Division name
Pediatrics
Zip code
701-0192
Address
Kawasaki Medical School 577, Matsushima, Kurashiki
TEL
086-462-1111
oo0612@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Oishi |
Organization
Kawasaki Medical School
Division name
Pediatrics
Zip code
701-0192
Address
Kawasaki Medical School 577, Matsushima, Kurashiki
TEL
086-462-1111
Homepage URL
https://h.kawasaki-m.ac.jp/data/dept_016/ekigaku_s_dtl/
oo0612@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Japanese Society and Technology agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki Okayama
Tel
086-462-1111
oo0612@med.kawasaki-m.ac.jp
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 14 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now we revised our past research.
Management information
Registered date
| 2018 | Year | 06 | Month | 14 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037607
| 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 |
