UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study about pathogenic diagnosis of Mycoplasma pneumoniae pneumonia
Title of the study (Brief title)	A study about pathogenic diagnosis of Mycoplasma pneumoniae pneumonia
Region	Japan

Condition
Condition	Mycoplasma pneumoniae pneumonia
Classification by specialty	Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recently, a rapid antigen detection assay for L7/L12 ribosomal protein (Ribotest Mycoplasma; Asahi Kasei) for diagnosis of Mycoplasma pneumoniae infection became available in Japan. However, the clinical usefulness of Ribotest is not established. To clarify the usefulness of Ribotest, we diagnosed with Mycoplasma pneumoniae pneumonia using Ribotest, both in non-epidemic period and in epidemic period.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sensitivities, specificities and positive predictive values of Ribotest for M. pneumoniae pneumonia
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	0 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	Eligible patients were otherwise healthy children 0 - 18 years of age who were admitted with community-acquired pneumonia
Key exclusion criteria	We excluded the subjects from whom throat swabs or paired serum samples were not obtained.
Target sample size	1000

Research contact person
Name of lead principal investigator	Naoko Nishimura
Organization	Konan Kosei Hospital
Division name	Departments of Pediatrics
Address	137 Ohmatsubara, Takaya-cho, Konan-shi, Aichi 483-8704, Japan
TEL	0587-51-3333
Email	naon@konan.jaaikosei.or.jp

Public contact
Name of contact person	Kensei Gotoh
Organization	Konan Kosei Hospital
Division name	Departments of Pediatrics
Address	137 Ohmatsubara, Takaya-cho, Konan-shi, Aichi 483-8704, Japan
TEL	0587-51-3333
Homepage URL
Email	idecc2b7@gmail.com

Sponsor
Institute	Konan Kosei Hospital
Institute
Department

Funding Source
Organization	Konan Kosei Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	We presented the results at the 47th annual meeting of the Japanese Society for Pediatric Infectious Diseases on November 1, 2015.
Other related information	Prospective study

Management information
Registered date	2017 Year 03 Month 31 Day
Last modified on	2017 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030752