UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006449
Receipt number R000007656
Scientific Title A population-based study of Streptococcus suis infections in humans in Phayao Province in the northern Thailand
Date of disclosure of the study information 2011/10/01
Last modified on 2011/10/01 17:21:50

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Basic information

Public title

A population-based study of Streptococcus suis infections in humans in Phayao Province in the northern Thailand

Acronym

An epidemiological study of Streptococcus suis infections in Thailand

Scientific Title

A population-based study of Streptococcus suis infections in humans in Phayao Province in the northern Thailand

Scientific Title:Acronym

An epidemiological study of Streptococcus suis infections in Thailand

Region

Asia(except Japan)


Condition

Condition

Streptococcus suis infection

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the incidence and the transmission mode of S. suis infection in the northern Thailand

Basic objectives2

Others

Basic objectives -Others

Clinical and microbiological study

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Detection of human case

Key secondary outcomes

Isolation of causative bacteria


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

After January 2010, the human case who is positive culture from the sterile sites such as blood or CSF and PCR for S. suis is positive at 7 hospitals in Phayao Provinces in the northern Thailand

Key exclusion criteria

None

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Oishi

Organization

Osaka University

Division name

Research Institute for Microbial Diseases

Zip code


Address

3-1 Yamadaoka, Suita, Osaka Prefecture

TEL

06-6879-4253

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Oishi

Organization

Osaka University

Division name

Research Institute for Microbial Diseases

Zip code


Address

3-1 Yamadaoka, Suita, Osaka Prefecture

TEL

06-6879-4253

Homepage URL


Email

oishik@biken.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Science and Culture

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Medical Sciences, Ministry of Public Health

Name of secondary funder(s)

Department of Medical Sciences, Ministry of Public Health


IRB Contact (For public release)

Organization


Address


Tel


Email



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

パヤオ病院、チェンカム病院


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 01 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

A prospective study of S. suis infections in humans was conducted in Phayao Province, in the northern Thailand to determine the incidence and the transmission mode of this disease in this region in 2010. Thirty-one cases with the case fatality rate of 15.6% were confirmed, and the estimated incidence in this year was 6.2 per 100000 in the general population in 2010. A peak incidence was found in May of 2010. The median age of patients were 53 and the male sex was 64.5%. Consumption of raw pork products was confirmed in 22 cases and the median incubation period (range) was 2 (0-11) days after consumption of raw pork products. Isolates from 31 cases were serotype 2 for 23 cases (74.2%) and serotype 14 for 8 cases (25.8%). The major sequence types (STs) found were ST1 (n=20) for serotypes 2 and ST105 (n=8) for serotype 14.

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

2009 Year 01 Month 11 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2010 Year 12 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete

2014 Year 12 Month 01 Day

Date analysis concluded

2014 Year 12 Month 01 Day


Other

Other related information

The epidemiological analyses suggested three possible clusters including 16 cases. In the largest possible cluster including 10 cases in Chiang Khum and the neighboring districts during May, 2010, the source of infection in four cases was estimated as the raw pork dish served in a restaurant in this district. The microbiological analysis confirmed that 3 of 4 cases associated with consumption of raw pork dish at this restaurant were attributable to an identical strain of serotype 2 with ST1 and pulsotypes of A2.


Management information

Registered date

2011 Year 10 Month 01 Day

Last modified on

2011 Year 10 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name