UMIN-CTR Clinical Trial

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
Email	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
Email	komorimo@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055626