UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002608 |
|---|---|
| Receipt number | 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 | 2019/10/17 14:27:48 |
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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 | Shinji |
| Middle name | |
| Last name | Teramoto |
Organization
National Hospital Organization, Tokyo National Hospital
Division name
Department of Pulmonary Medicine
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL
042-491-2111
shinjit-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Teramoto |
Organization
National Hospital Organization, Tokyo National Hospital
Division name
Department of Pulmonary Medicine
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL
042-491-2111
Homepage URL
shinjit-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization, Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Healthy, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
National Hospital Organization, Tokyo National Hospital
Address
3-1-1 Takeoka, Kiyose, Tokyo, Japan
Tel
042-491-2111
shinjit-tky@umin.ac.jp
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 01 | Day |
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
| 2019 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003182
| Research Plan | |
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| 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 |
