Human Suis and Pig Diseases in Northern Vietnam

NCT01434719 | Completed

• 1 other identifier: 02ZN
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Streptococcus Suis Infection

Keywords

Streptococcus suis; Sepsis; Porcine Respiratory and Reproductive System virus; Pig disease; Epidemiology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 1 year

Secondary Outcomes (2)

• Number of human S. suis cases

  One year

• Number of pig disease outbreaks

  One year

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• \- Unable to collect patient's spatial data at commune level.
• Group 2: controls
• Diagnosis as sepsis at hospital admission (based on clinical symptoms or laboratory evidence)
• Admission date between 01/01/2010 and 31/12/2010
• 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

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• National Hospital for Tropical Diseases, Hanoi, Vietnam: collaborator

Study Sites (1)

National Hospital for Tropical Diseases

Hanoi, Hanoi, Vietnam

Location

Related Links

• OUCRU studies public site

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kinh V Nguyen, PhD

  National Hospital for Tropical Diseases

  PRINCIPAL INVESTIGATOR

• Heiman F Wertheim, PhD

  Oxford University Clinical Research Unit - Hanoi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: September 15, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: November 15, 2016

Record last verified: 2013-11

Locations

VN (1)