Human Suis and Pig Diseases in Northern Vietnam

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition
Streptococcus Suis Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Spatial and Temporal Associations Between Human Streptococcus Suis Infections and Pig Diseases in Northern Vietnam, 2010

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 350
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434719

Contacts
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

Locations
Vietnam
National Hospital for Tropical Diseases Recruiting
Hanoi, Vietnam
Contact: Kinh F Nguyen, PhD    +84 4 35764305    kinhvaac@yahoo.com   
Contact: Phu D Vu, Dr    +84 4 35764305    vudinhphu@hotmail.com   
Principal Investigator: Kinh V Nguyen, PhD         
Sub-Investigator: Ha H Nguyen, Dr         
Sub-Investigator: Trung V Nguyen, PhD         
Sub-Investigator: Trinh T Dao, MSc         
Sub-Investigator: Phu D Vu, Dr         
Sub-Investigator: Peter Horby, Dr         
Sub-Investigator: Huong TL Vu, MSc         
Principal Investigator: Heiman F Wertheim, PhD         
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
National Hospital for Tropical Diseases, Vietnam
Investigators
Principal Investigator: Kinh V Nguyen, PhD National Hospital for Tropical Diseases
Principal Investigator: Heiman F Wertheim, PhD Oxford University Clinical Research Unit - Hanoi
  More Information

Additional Information:
No publications provided

Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01434719     History of Changes
Other Study ID Numbers: 02ZN
Study First Received: April 6, 2011
Last Updated: November 21, 2013
Health Authority: Vietnam: Ministry of Health

Keywords provided by Oxford University Clinical Research Unit, Vietnam:
Streptococcus suis
Sepsis
Porcine Respiratory and Reproductive System virus
Pig disease
Epidemiology

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 19, 2014