UMIN-CTR Clinical Trial

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
Email	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/
Email	oo0612@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037607