Streptococcus Suis InfectionNCT01434719
Human Suis and Pig Diseases in Northern Vietnam
An observational study of Streptococcus Suis Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
This study aim to test the hypothesis that human S.suis infections are associated in time and space with outbreaks of Porcine Reproductive and Respiratory Syndrome (PRRS) virus or other diseases in pigs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Streptococcus Suis Infection
- How many people
- 273 participants
- Where
- 1 siteVietnam
- Study dates
- Nov 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population under study is the population from which cases of S.suis infection admitted to NHTD arise. Sepsis patients are selected to present the population of interest under the following assumptions: * they are representative of the background exposure rate of the population from which cases come from, * their diagnosis is independent of the exposure of interest, * they are similar to the S.suis cases in terms of care seeking and referral patterns.
Who may be able to join
- Date of specimen (blood or CSF sample) collection is between 01/01/2010 to 31/12/2010; and
- S.suis infection confirmed by either CSF or blood culture or PCR; or
- Meet the criteria for a probable case as above (in absence of laboratory confirmation).
- Diagnosis as sepsis at hospital admission (based on clinical symptoms or laboratory evidence)
- Admission date between 01/01/2010 and 31/12/2010
Who cannot join
- Unable to collect patient's spatial data at commune level.
- Group 2: controls
- Symptoms of meningitis
- Clinically a high suspicion of S. suis infection (culture and PCR negative) as determined by doctor.
- Laboratory culture or PCR result positive for S.suis infection
- HIV infection
- Unable to collect patient's spatial data at commune level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spatial and Temporal Associations Between Human Streptococcus Suis Infections and Pig Diseases in Northern Vietnam, 2010
This study aim to test the hypothesis that human S.suis infections are associated in time and space with outbreaks of Porcine Reproductive and Respiratory Syndrome (PRRS) virus or other diseases in pigs.
Read the detailed description
Streptococcus suis is a zoonotic agent which can cause severe systemic infection in humans exposed to infected pigs or pig derived products. Over 700 cases have been reported worldwide, most of them were in China and Vietnam in the last few years.
In Vietnam, S. suis infection in adults is common, and patients with S.suis are often admitted to the National Hospital for Tropical Diseases (NHTD), a tertiary referral hospital for infectious diseases in northern Vietnam. In 2007, 50 laboratory confirmed cases with S.suis were reported at this hospital, and in 2010, 65 laboratory confirmed S.suis cases have been identified by September. Pig breeding and pork consumption is popular in Vietnam, with the majority of pigs and meat supply channelled from small-scaled un-controlled farmers and slaughterhouses, which pose a great potential health risk to people involved in the chain. A case-control study conducted in southern Vietnam showed that occupational exposure, raising pigs at home and consuming high-risk dishes from pigs significantly increased the risk of S. suis infection.
It has been suggested that the incidence of human S. suis cases is possibly linked to the occurrence of Porcine Respiratory and Reproductive System (PRRS) virus outbreaks in northern Vietnam. In 2010, the disease has spread to over 30 provinces over the country, with many outbreaks reported in northern provinces in the period from April to July. Field observations in other countries showed that PRRS virus infection increased pig's susceptibility to S. suis infection, including serotype 2 and 7. Therefore, PRRS virus outbreaks might have increased the risk of S. suis transmission to humans through exposure to pigs with PRRS virus infection and concomitant S. suis disease. Nevertheless, sufficient data are not available to confirm or refute this hypothesis. Knowledge of spatial and temporal relationships between human S.suis infections and disease outbreaks in pigs can increase our understanding of risk factors for human S.suis infection and support disease prevention and preparedness in the community.
- Conditions
- Streptococcus Suis Infection
- Keywords
- Streptococcus suis, Sepsis, Porcine Respiratory and Reproductive System virus, Pig disease, Epidemiology
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| S.suis cases | This group consists of human cases with S.suis infection (confirmed or probable) admitted to National Hospital for Tropical Diseases in 2010. | |
| Sepsis controls | This group consists of hospital controls diagnosed with sepsis (not caused by S.suis) admitted to National Hospital for Tropical Diseases in 2010. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal proximity to the nearest pig outbreak of human cases versus human controls
The number of days separating identified nearest pig outbreak and identified human cases of S. suis versus the number of days separating identified nearest pig outbreak and human controls.
Measured: Up to 1 year
Spatial proximity to the nearest pig outbreak of human cases versus human controls
The number of kilometers separating the identified nearest pig outbreak and identified human cases of S. suis versus the number of kilometers separating the identified nearest pig outbreak and human controls.
Measured: Up to 1 year
Secondary outcomes (2)
Number of human S. suis cases
Total number of human S.suis cases recorded at NHTD in 2010.
Measured: One year
Number of pig disease outbreaks
Total number of pig outbreaks identified within 2010 in the Northern region.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Suis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Responsible party
- Sponsor
- Investigators
- Kinh V Nguyen, PhD, Principal investigator, National Hospital for Tropical DiseasesHeiman F Wertheim, PhD, Principal investigator, Oxford University Clinical Research Unit - Hanoi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434719
- Sponsor's protocol ID
- 02ZN
- Status last verified
- Nov 2013
- First submitted
- 6 Apr 2011
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial and Temporal Associations Between Human Streptococcus Suis Infections and Pig Diseases in Northern Vietnam, 2010
- ClinicalTrials.gov ID
- NCT01434719
- Acronym / sponsor ID
- 02ZN
- Conditions
- Streptococcus Suis Infection
- Keywords
- Streptococcus suis, Sepsis, Porcine Respiratory and Reproductive System virus, Pig disease, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- National Hospital for Tropical Diseases, Hanoi, Vietnam
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim to test the hypothesis that human S.suis infections are associated in time and space with outbreaks of Porcine Reproductive and Respiratory Syndrome (PRRS) virus or other diseases in pigs.
Detailed description
Streptococcus suis is a zoonotic agent which can cause severe systemic infection in humans exposed to infected pigs or pig derived products. Over 700 cases have been reported worldwide, most of them were in China and Vietnam in the last few years.
In Vietnam, S. suis infection in adults is common, and patients with S.suis are often admitted to the National Hospital for Tropical Diseases (NHTD), a tertiary referral hospital for infectious diseases in northern Vietnam. In 2007, 50 laboratory confirmed cases with S.suis were reported at this hospital, and in 2010, 65 laboratory confirmed S.suis cases have been identified by September. Pig breeding and pork consumption is popular in Vietnam, with the majority of pigs and meat supply channelled from small-scaled un-controlled farmers and slaughterhouses, which pose a great potential health risk to people involved in the chain. A case-control study conducted in southern Vietnam showed that occupational exposure, raising pigs at home and consuming high-risk dishes from pigs significantly increased the risk of S. suis infection.
It has been suggested that the incidence of human S. suis cases is possibly linked to the occurrence of Porcine Respiratory and Reproductive System (PRRS) virus outbreaks in northern Vietnam. In 2010, the disease has spread to over 30 provinces over the country, with many outbreaks reported in northern provinces in the period from April to July. Field observations in other countries showed that PRRS virus infection increased pig's susceptibility to S. suis infection, including serotype 2 and 7. Therefore, PRRS virus outbreaks might have increased the risk of S. suis transmission to humans through exposure to pigs with PRRS virus infection and concomitant S. suis disease. Nevertheless, sufficient data are not available to confirm or refute this hypothesis. Knowledge of spatial and temporal relationships between human S.suis infections and disease outbreaks in pigs can increase our understanding of risk factors for human S.suis infection and support disease prevention and preparedness in the community.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S.suis cases | – | –This group consists of human cases with S.suis infection (confirmed or probable) admitted to National Hospital for Tropical Diseases in 2010. |
| Sepsis controls | – | –This group consists of hospital controls diagnosed with sepsis (not caused by S.suis) admitted to National Hospital for Tropical Diseases in 2010. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population under study is the population from which cases of S.suis infection admitted to NHTD arise. Sepsis patients are selected to present the population of interest under the following assumptions: * they are representative of the background exposure rate of the population from which cases come from, * their diagnosis is independent of the exposure of interest, * they are similar to the S.suis cases in terms of care seeking and referral patterns.
Key inclusion criteria (5 listed)
- Date of specimen (blood or CSF sample) collection is between 01/01/2010 to 31/12/2010; and
- S.suis infection confirmed by either CSF or blood culture or PCR; or
- Meet the criteria for a probable case as above (in absence of laboratory confirmation).
- Diagnosis as sepsis at hospital admission (based on clinical symptoms or laboratory evidence)
- Admission date between 01/01/2010 and 31/12/2010
Key exclusion criteria (7 listed)
- Unable to collect patient's spatial data at commune level.
- Group 2: controls
- Symptoms of meningitis
- Clinically a high suspicion of S. suis infection (culture and PCR negative) as determined by doctor.
- Laboratory culture or PCR result positive for S.suis infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temporal proximity to the nearest pig outbreak of human cases versus human controls
Time frame: Up to 1 year
The number of days separating identified nearest pig outbreak and identified human cases of S. suis versus the number of days separating identified nearest pig outbreak and human controls.
Spatial proximity to the nearest pig outbreak of human cases versus human controls
Time frame: Up to 1 year
The number of kilometers separating the identified nearest pig outbreak and identified human cases of S. suis versus the number of kilometers separating the identified nearest pig outbreak and human controls.
2 secondary outcomes
Number of human S. suis cases
Time frame: One year
Number of pig disease outbreaks
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- OUCRU studies public siteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kinh V Nguyen, PhD principal investigator
National Hospital for Tropical Diseases
Heiman F Wertheim, PhD principal investigator
Oxford University Clinical Research Unit - Hanoi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Suis Infection, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal proximity to the nearest pig outbreak of human cases versus human controls (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.