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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015006
Receipt No. 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

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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
Email 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
Email yimamura@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017454

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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