UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015006 |
|---|---|
| Receipt number | R000017454 |
| Scientific Title | A prospective multicenter study of nursing and healthcare associated pneumonia in Japan. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2016/07/19 11:23:11 |
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Basic information
Public title
A prospective multicenter study of nursing and healthcare associated pneumonia in Japan.
Acronym
A prospective multicenter study of nursing and healthcare associated pneumonia in Japan.
Scientific Title
A prospective multicenter study of nursing and healthcare associated pneumonia in Japan.
Scientific Title:Acronym
A prospective multicenter study of nursing and healthcare associated pneumonia in Japan.
Region
| Japan |
Condition
Condition
Nursing and healthcare associated pneumonia (NHCAP)
Classification by specialty
| Pneumology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical features of NHCAP in Japan.
Basic objectives2
Others
Basic objectives -Others
To evaluate the newly created Japanese NHCAP guidelines.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 30-day mortality rates
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
NHCAP patients
Key exclusion criteria
1. Patients who has been already effectively treated before entry the study.
2. Patients who are impossible to evaluated clinical features accurately or to follow clinical course.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiga Miyazaki |
Organization
Nagasaki University
Division name
Nagasaki University hosopital
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
TEL
095-819-7273
taiga-m@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Imamura |
Organization
Nagasaki University
Division name
Nagasaki University hosopital
Zip code
Address
1-7-1 Sakamoto, Nagasaki, Nagasaki
TEL
095-819-7273
Homepage URL
yimamura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | 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
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 27 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
To evaluate clinical information of NHCAP cases listed below.
1. Patient characteristics
2. Antibiotics treatment
3. Other drugs
4. Other treatment
5. Efficacy
6. Safety
7. Outcome
Management information
Registered date
| 2014 | Year | 08 | Month | 31 | Day |
Last modified on
| 2016 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
