UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018676 |
|---|---|
| Receipt number | 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 14:21:46 |
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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
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
nao@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021600
