UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043756 |
|---|---|
| Receipt number | 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 17:01:09 |
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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
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
mharuka@nagasaki-u.ac.jp
Sponsor or person
Institute
Institute of Tropical Medicine, Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047581
| 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 |
