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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002608
Receipt No. R000003182
Scientific Title NHO network group multi-center study on features of health-care associated pneumonia (HCAP) in Japan -roles of HCAP on acute exacerbation in respiratory failure –
Date of disclosure of the study information 2009/10/09
Last modified on 2009/10/09

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Basic information
Public title NHO network group multi-center study on features of health-care associated pneumonia (HCAP) in Japan -roles of HCAP on acute exacerbation in respiratory failure –
Acronym NHO network group study on HCAP in Japan (HCAP-NHO-Japan)
Scientific Title NHO network group multi-center study on features of health-care associated pneumonia (HCAP) in Japan -roles of HCAP on acute exacerbation in respiratory failure –
Scientific Title:Acronym NHO network group study on HCAP in Japan (HCAP-NHO-Japan)
Region
Japan

Condition
Condition health-care associated pneumonia, Community-acquired pneumonia,
Chronic respiratory diseases,
Chronic obstructive pulmonary disease (COPD), Chronic respiratory failure

Chronic respiratory failure,
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the frequency, and features of HCAP and CAP in hospitalized patients and to investigate roles of HCAP on the respiratory failure and its exacerbation
Basic objectives2 Others
Basic objectives -Others The utility of the diagnostic criteria for HCAP based on ATS/IDSA guidelines 2005
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Retrospective assessment of characteristics of HCAP or CAP, background disease, disease severity, pathogen distribution, antibiotic regimens, duration of antibiotic use, escalation and/or De-escalation of antibiotics, frequency of drug-resistant pathogens, treatment efficacy, prognosis, hospital stays lenghts,
2.Prospecivte assessment of characteristics of HCAP or CAP, antibiotic regimens, duration of antibiotic use, escalation and/or De-escalation of antibiotics, treatment efficacy, prognosis, hospital stay lenghts,
Key secondary outcomes Clinical significance of disease severity assessment on the prediction of the pneumonia prognosis

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 1)Hospitalized patients with pneumonia at NHO respiratory research network Hospitals
2) Patients are aged greater than 20 years
Key exclusion criteria 1) Patients under treatment of radiotherapy and immunosuppressant at present
2) Patients who have serious acute diseases obviously
3) Patients with hospital-acquired pneumonia
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Teramoto
Organization National Hospital Organization, Tokyo National Hospital
Division name Department of Pulmonary Medicine
Zip code
Address 3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL 042-491-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Teramoto
Organization National Hospital Organization, Tokyo National Hospital
Division name Department of Pulmonary Medicine
Zip code
Address 3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL 042-491-2111
Homepage URL
Email shinjit-tky@umin.ac.jp

Sponsor
Institute National Hospital Organization, Tokyo National Hospital
Institute
Department

Funding Source
Organization Ministry of Healthy, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor NHO respiratory research network group
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
2009 Year 10 Month 09 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information 1. Retrospective assessment of characteristics of HCAP or CAP, background disease, disease severity, pathogen distribution, antibiotic regimens, duration of antibiotic use, escalation and/or De-escalation of antibiotics, frequency of drug-resistant pathogens, treatment efficacy, prognosis, hospital stays lengths,
2.Prospecivte assessment of characteristics of HCAP or CAP, antibiotic regimens, duration of antibiotic use, escalation and/or De-escalation of antibiotics, treatment efficacy, prognosis, hospital stay lengths,

Management information
Registered date
2009 Year 10 Month 09 Day
Last modified on
2009 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003182

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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