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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018676
Receipt No. R000021600
Scientific Title Effects of prednisolone against Mycoplasma pneumoniae pneumonia in adults
Date of disclosure of the study information 2015/09/01
Last modified on 2019/08/19

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Basic information
Public title Effects of prednisolone against Mycoplasma pneumoniae pneumonia in adults
Acronym M. pneumoniae pneumonia and predonisolone
Scientific Title Effects of prednisolone against Mycoplasma pneumoniae pneumonia in adults
Scientific Title:Acronym M. pneumoniae pneumonia and predonisolone
Region
Japan

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

Objectives
Narrative objectives1 Effect of prednisolone
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Stability of clinical findings
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prednisolone
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Community-acquired pneumonia
PCR positive for M. pneumoniae
Key exclusion criteria Immunosuprresion
Hospital acquired pneumonia
Health-care associated pneumonia
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Miyashita
Organization Kawasaki Medical School
Division name Department of Internal Medicine 1
Zip code
Address 2-1-80 Nakasange, Kita-ku, Okayama
TEL 086-225-2111
Email nao@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Miyashita
Organization Kawasaki Medical School
Division name Department of Internal Medicine 1
Zip code
Address 2-1-80 Nakasange, Kita-ku, Okayama
TEL 086-225-2111
Homepage URL
Email nao@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 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
2015 Year 10 Month 20 Day
Date of IRB
2015 Year 12 Month 02 Day
Anticipated trial start date
2016 Year 09 Month 07 Day
Last follow-up date
2017 Year 06 Month 13 Day
Date of closure to data entry
2017 Year 06 Month 13 Day
Date trial data considered complete
2017 Year 06 Month 13 Day
Date analysis concluded
2017 Year 06 Month 15 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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