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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043756
Receipt No. R000047581
Scientific Title Nationwide evaluation of Streptococcus pneumoniae serotype distribution among adults with community-onset pneumonia in Japan
Date of disclosure of the study information 2021/03/26
Last modified on 2021/03/26

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Basic information
Public title Nationwide evaluation of Streptococcus pneumoniae serotype distribution among adults with community-onset pneumonia in Japan
Acronym Nationwide evaluation of Streptococcus pneumoniae serotype distribution among adults with community-onset pneumonia in Japan
Scientific Title Nationwide evaluation of Streptococcus pneumoniae serotype distribution among adults with community-onset pneumonia in Japan
Scientific Title:Acronym Nationwide evaluation of Streptococcus pneumoniae serotype distribution among adults with community-onset pneumonia in Japan
Region
Japan

Condition
Condition Community Onset pneumonia; Community acquired and Healthcare associated pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To establish the serotype distribution of S.pneumoniae isolates obtained from adult pneumonia patients
2. To describe the clinical characteristics of community-onset pneumonia associated with individual serotypes of S.pneumoniae
3. To advocate a precise pneumococcal vaccine policy
Basic objectives2 Others
Basic objectives -Others investigation
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To establish the serotype distribution of S.pneumoniae isolates obtained from adult pneumonia patients in Japan.
Key secondary outcomes 1. To describe the clinical characteristics of community-onset pneumonia associated with individual serotypes of S.pneumoniae
2. To establish antibiotic susceptibility patterns and MLST profiles for S.pneumoniae isolates obtained from adult patients with COP

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 1. Adults patients with community-onset pneumoniae (having symptoms compatible with pneumonia (i.e. fever, hypothermia, chills or rigors, cough, sputum, pleuritic chest pain, dyspnea, tachypnea, or malaise) and with new pulmonary infiltrates on chest X-ray or computed tomography (CT) scan (consistent with pneumonia.)
2. With isolated S.pneumoniae from respiratory specimen, blood, or pleural fluid
Key exclusion criteria 1. A case diagnosed with pneumonia 48 hours or more after admission to the hospital
2. Patients who previously included in the study within past 30 days
3. Patients who declined to participate in hospital research via opt-out process
Target sample size 3000

Research contact person
Name of lead principal investigator
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 Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
TEL 095-819-7842
Email komorimo@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Haruka,Konosuke
Middle name
Last name Maeda, Morimoto
Organization Institute of Tropical Medicine, Nagasaki University
Division name Department of Respiratory Infections
Zip code 852-8523
Address Sakamoto, Nagasaki city, Nagasaki, 852-8523,Japan
TEL 095-819-7842
Homepage URL
Email mharuka@nagasaki-u.ac.jp

Sponsor
Institute Institute of Tropical Medicine, Nagasaki University
Institute
Department

Funding Source
Organization Pfizer Inc.
Organization
Division
Category of Funding Organization Other
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, Nagasaki, 852-8523,Japan
Tel 095-819-7803
Email soum-nekken@ml.nagasaki-u.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 京都大学(京都)、近森病院(高知県)、他約20施設

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 26 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 14 Day
Date of IRB
2019 Year 12 Month 11 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2023 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The anonymized data of pneumococcal strain and patient's information including age, sex, underlying diseases, vaccination history, the severity of pneumonia, and hospital death or not, are used.

Management information
Registered date
2021 Year 03 Month 26 Day
Last modified on
2021 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047581

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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