UMIN-CTR Clinical Trial

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