UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048813 |
|---|---|
| Receipt number | R000055626 |
| Scientific Title | Nationwide Surveillance of Adult Acute Respiratory Tract Infection Hospitalization in Japan |
| Date of disclosure of the study information | 2022/09/05 |
| Last modified on | 2022/09/01 16:20:02 |
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Basic information
Public title
Nationwide Surveillance of Adult Acute Respiratory Tract Infection Hospitalization in Japan
Acronym
Nationwide Surveillance of Adult Acute Respiratory Tract Infection Hospitalization in Japan
Scientific Title
Nationwide Surveillance of Adult Acute Respiratory Tract Infection Hospitalization in Japan
Scientific Title:Acronym
Nationwide Surveillance of Adult Acute Respiratory Tract Infection Hospitalization in Japan
Region
| Japan |
Condition
Condition
Hospitalized community-acquired pneumonia/acute respiratory syndrome
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the proportion of hospitalized CAP and other hospitalized ARI associated with selected common viral and bacterial pathogens.
Basic objectives2
Others
Basic objectives -Others
To estimate the age-specific, population-based incidence of hospitalized CAP and other hospitalized ARI, overall and by selected common pathogens.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The overall proportion of hospitalized CAP and other hospitalized ARI with laboratory-confirmed S. pneumoniae, with serotypes identified by sputum nanofluidic multiplex PCR and traditional serotyping of isolates identified by culture.
Key secondary outcomes
The overall proportion of hospitalized CAP and other hospitalized ARI with RSV.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients admitted to study hospital for acute respiratory infection with radiography (chest CT or x-ray) conducted.
Key exclusion criteria
Patients diagnosed with HAP
Patients who reside outside the hospital's catchment area (government-defined secondary medical area)
Previously enrolled in this study (within the past 14 days).
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Koya |
| Middle name | |
| Last name | Ariyoshi |
Organization
Institute of Tropical Medicine, Nagasaki University
Division name
Department of Clinical Medicine
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki-city
TEL
0958197842
kari@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Konosuke |
| Middle name | |
| Last name | Morimoto |
Organization
Institute of Tropical Medicine, Nagasaki University
Division name
Department of Respiratory Infections
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki-city
TEL
0958197842
Homepage URL
komorimo@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc
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
Institutional Review Board at Institutional of Tropical Medicine at Nagasaki University
Address
1-12-4 Sakamoto, Nagasaki-city
Tel
0958197842
komorimo@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
70109063
Org. issuing International ID_1
Pfizer Inc
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
JA北海道厚生連旭川厚生病院、旭川医療センター、亀田総合病院、近森病院、高知病院、十善会病院、長崎みなとメディカルセンター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not Applicable
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055626
| 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 |
