Human Suis and Pig Diseases in Northern Vietnam

This study is currently recruiting participants.
Verified November 2013 by Oxford University Clinical Research Unit, Vietnam
Sponsor:
Collaborator:
National Hospital for Tropical Diseases, Vietnam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01434719
First received: April 6, 2011
Last updated: November 21, 2013
Last verified: November 2013

April 6, 2011
November 21, 2013
November 2010
November 2014   (final data collection date for primary outcome measure)
  • Temporal proximity to the nearest pig outbreak of human cases versus human controls [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The number of days seperating identified nearest pig outbreak and identified human cases of S. suis versus the number of days seperating 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 ] [ Designated as safety issue: No ]
    The number of kilometers seperating the identified nearest pig outbreak and identified human cases of S. suis versus the number of kilometers seperating the identified nearest pig outbreak and human controls.
  • Temporal proximity to pig S. suis cases of human controls versus human cases [ Time Frame: Every day for 1 year ] [ Designated as safety issue: No ]
    The number of days seperating identified pig cases of S. suis and identified human cases of S. suis versus the number of days seperating identified pig cases of S. suis and human controls.
  • Spatial proximity to pig S. suis cases of human controls versus human cases [ Time Frame: Every day for 1 year ] [ Designated as safety issue: No ]
    The number of kilometers seperating identified pig cases of S. suis and identified human cases of S. suis versus the number of kilometers seperating identified pig cases of S. suis and human controls.
Complete list of historical versions of study NCT01434719 on ClinicalTrials.gov Archive Site
  • Number of human S. suis cases [ Time Frame: One year ] [ Designated as safety issue: No ]
    Total number of human S.suis cases recorded at NHTD in 2010.
  • Number of pig disease outbreaks [ Time Frame: One year ] [ Designated as safety issue: No ]
    Total number of pig outbreaks identified within 2010 in the Northern region.
  • Number of human S. suis cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Total number of human S.suis cases recorded.
  • Geographical distribution of human S. suis cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of human S. suis cases per kilometer squared.
  • Monthly prevelance of human S. suis infection [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of human S. suis cases per month.
  • Severity of disease in human S. suis cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of human S. suis cases which progress to clinical severity.
  • Number of pig S. suis cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Total number of pig S.suis cases recorded.
  • Geographical distribution of pig S. suis cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of pig S. suis cases per kilometer squared.
  • Monthly prevelance of pig S. suis infection [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of pig S. suis cases per month to demonstrate out breaks.
  • Pathogen causes of pig S. suis cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of each identified pathogen in the total annual count of pig S. suis cases.
  • Geographical distribution of S. suis causing pathogens in pig cases [ Time Frame: Every month for 12 months ] [ Designated as safety issue: No ]
    Number of each identified pathogen per meter squared.
Not Provided
Not Provided
 
Human Suis and Pig Diseases in Northern Vietnam
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.
Streptococcus Suis Infection
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
November 2014
November 2014   (final data collection date for primary outcome measure)

Group 1: cases

Inclusion Criteria:

  • 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).

Exclusion Criteria:

- Unable to collect patient's spatial data at commune level.

Group 2: controls

Inclusion Criteria:

  • Diagnosis as sepsis at hospital admission (based on clinical symptoms or laboratory evidence)
  • Admission date between 01/01/2010 and 31/12/2010

Exclusion Criteria:

  • 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
Both
Not Provided
No
Contact: Heiman F Wertheim, PhD +84 4 3576 4320 heiman.wertheim@gmail.com
Contact: Huong TL Vu, MSc +84 4 3576 4320 huongvtl@oucru.org
Vietnam
 
NCT01434719
02ZN
No
Oxford University Clinical Research Unit, Vietnam
Oxford University Clinical Research Unit, Vietnam
National Hospital for Tropical Diseases, Vietnam
Principal Investigator: Kinh V Nguyen, PhD National Hospital for Tropical Diseases
Principal Investigator: Heiman F Wertheim, PhD Oxford University Clinical Research Unit - Hanoi
Oxford University Clinical Research Unit, Vietnam
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP