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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019702
Receipt No. R000022760
Scientific Title A multicenter, prospective observational study for severe sepsis induced by Streptococcus pneumoniae, beta-hemolytic streptococci, and Staphylococcus aureus
Date of disclosure of the study information 2015/11/16
Last modified on 2020/05/13

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Basic information
Public title A multicenter, prospective observational study for severe sepsis induced by Streptococcus pneumoniae, beta-hemolytic streptococci, and Staphylococcus aureus
Acronym Epidemiology of GPC-induced severe sepsis (FORECAST GPC-SEPSIS)
Scientific Title A multicenter, prospective observational study for severe sepsis induced by Streptococcus pneumoniae, beta-hemolytic streptococci, and Staphylococcus aureus
Scientific Title:Acronym Epidemiology of GPC-induced severe sepsis (FORECAST GPC-SEPSIS)
Region
Japan

Condition
Condition S. pneumonia, beta-hemolytic streptococci, and S. aureus-induced severe sepsis
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to elucidate the epidemiology, pathogen genomics, diagnosis/treatment, and pathophysiology/pathogenesis of severe sepsis induced-by S. pneumoniae, beta-hemolytic streptococci, and S. aureus
Basic objectives2 Others
Basic objectives -Others 28-day and hospital mortality
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The epidemiology of severe sepsis induced by S. pneumonia, beta-hemolytic streptococci, and S. aureus (hospital mortality)
Key secondary outcomes 1. pathogen genomics
2. The diagnosis/treatment
3. The pathophysiology/pathogenesis of organ dysfunction

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who met the following two inclusion criteria; (1) severe sepsis according to SCCM/ACCP 1992 and SCC/ESICM/ACCP/ATS/SIS2003 and SSCG 2012, (2) S. pneumonia, beta-hemolytic streptococci, or S. aureus identified from the blood or infection site
Key exclusion criteria None
Target sample size 258

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name GANDO
Organization Hokkaido University Graduate School of Medicine
Division name Acute and Critical Care Medicine
Zip code 060-8638
Address N15W7, Kita-ku, Sapporo
TEL +81-11-706-7377
Email gando@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Kiyohiko
Middle name
Last name SATO
Organization Japanese Association for Acute Medicine
Division name Office
Zip code 113-0033
Address 3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5840-9870
Homepage URL http://www.jaam.jp/html/jaamforecast/index.html
Email editorial-jaam@umin.net

Sponsor
Institute Japanese Association for Acute Medicine
Institute
Department

Funding Source
Organization Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Infectious Diseases, Keio University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Graduate School of Medicine
Address 15 jyou nishi 7, Kita-ku, Sapporo City
Tel +81-11-706-7377
Email gando@med.hokudai.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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 16 Day

Related information
URL releasing protocol http://www.jaam.jp/html/jaamforecast/index.html
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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 05 Day
Date of IRB
2016 Year 05 Month 02 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information Study design: Prospective Cohort study

Patients enrollment method: We recruit all patients who visit ER or are admitted to a ward of the participated hospitals between January 1 and December 31, 2016, and fulfilling the following two inclusion criteria; (1) severe sepsis according to SCCM/ACCP 1992 and SCC/ESICM/ACCP/ATS/SIS2003 and SSCG 2012, (2) S. pneumonia, beta-hemolytic streptococci, or S. aureus identified from the blood or infection site.

Data collection: Relationships between patients' background factors (age, gender, comorbidities, etc), infection site, pathogen genomics, laboratory findings, organ dysfunction, etc and outcome (hospital mortality, 28-day mortality, hospital stay, etc)

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2020 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022760

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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