UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000019702
Receipt number	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	2020/11/12 10:33:09

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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

S. pneumonia, beta-hemolytic streptococci, and S. aureus-induced severe sepsis

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

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 or person

Institute

Japanese Association for Acute Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Published

Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/32489668/

Number of participants that the trial has enrolled

Results

62 were included in the current study (29 cases with S. pneumoniae sepsis and 33 with BHS). The CCI and completion of a 3-h bundle did not differ between normal and high virulence groups. Risk of 28-day mortality was significantly higher for high-virulence compared to normal-virulence when adjusted for CCI and completion of a 3-h bundle (Cox proportional hazards regression analysis, hazard ratio 3.848; 95% confidence interval, 1.108-13.370; P = 0.034).

Results date posted

2020 Year 11 Month 12 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020 Year 05 Month 31 Day

Baseline Characteristics

Combined detailed analysis of patient characteristics and treatment as well as bacterial virulence factors, which all play a central role in the cause of infections leading to severe illness, has not been reported. We aimed to describe the patient characteristics (Charlson comorbidity index [CCI]), treatment (3-h sepsis bundle), and outcomes in relation to bacterial virulence of Streptococcus pneumoniae and beta-hemolytic Streptococcus (BHS).

Participant flow

Adult patients (over 16 years) with severe sepsis or septic shock based on sepsis-2 criteria were included in the FORECAST study. We included patients aged 16 years or older who were diagnosed with S. pneumoniae and beta-hemolytic Streptococcus sepsis.Patients with unknown virulence (i.e., detailed examination of virulence factor was not performed because isolates were not sent to the laboratory of Keio University School, Department of Infectious Diseases) were excluded.

Adverse events

none

Outcome measures

28-days mortality

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

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 11 Month 12 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022760

Research Plan
Registered date	File name
2020/11/12	2_4kenkyu0601.doc

Research case data specifications
Registered date	File name

Research case data
Registered date	File name