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NCT Number: NCT06859619

Serological Measurement of Montpellier Professionals' Contacts with Infectious Agents Responsible for Animal-borne Diseases

Zoonoses and arboviroses refer to a group of diseases transmitted from animals to humans, either directly or indirectly (via mosquitoes, ticks or contact with contaminated environments). Most of these diseases are found in certain tropical zones, but global warming and increased international trade are modifying their geographical distribution, with a gradual trend towards temperate regions. A number of these pathogens have already been detected in Occitania, including dengue fever, West Nile, leishmaniasis and Q fever. Given the region's high mosquito population and favorable climatic conditions, other zoonoses have a strong potential to appear in the region, or may already be circulating at a low level. The study focuses on 18 pathogens selected for their potential to emerge and establish themselves in the Occitanie region: Leishmaniasis, Leptospirosis, Brucellosis, Q fever, Rickettsiosis, Tularemia, Psittacosis, Lyme disease, Tick-borne encephalitis, Hantavirus, Hepatitis E virus, Dengue virus, Zika virus, Chikungunya virus, West-Nile virus, Usutu virus, Toscana virus, Crimean-Congo haemorrhagic fever virus.

The aim of the study is to find out whether patients have antibodies against these infectious agents, which would indicate that they have been exposed to them in the past, even in the absence of symptoms.

Describing the circulation of these pathogens will enable to implement appropriate public health measures to avoid the risk of epidemics (mosquito control, informing professionals, etc.), as well as to assess the risk incurred in the workplace and have this risk recognized by the healthcare system.

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Key information

Conditions

Leishmaniasis Alphavirus Infections Arbovirus Infections Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Brain Diseases Brucellosis Bunyaviridae Infections Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Chikungunya Fever Chikungunya Virus Infection Chlamydiaceae Infections Chlamydophila Infections Crimean-Congo Haemorrhagic Fever Virus Dengue Virus Digestive System Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Tick-Borne Encephalitis, Viral Euglenozoa Infections Flaviviridae Infections Flavivirus Infections Gram-Negative Bacterial Infections Hantaviral Infection Nos Hantavirus Infections Hantavirus Pulmonary Syndrome Hepatitis Hepatitis E Hepatitis, Viral, Human Infections Infectious Encephalitis Leptospirosis Liver Diseases Lyme Disease Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases Parasitic Diseases Protozoan Infections Psittacosis Q Fever RNA Virus Infections Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Rickettsia Infections Rickettsiaceae Infections Rickettsiosis Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Spirochaetales Infections Tick-Borne Diseases Tick-borne Encephalitis Togaviridae Infections Toscana Virus Tularemia Usutu Virus Vector Borne Diseases Virus Diseases West Nile Virus Zika Virus Zika Virus Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Of Montpellier

Montpellier, herault, 34295, France

Location contact

CHARLOTTE BOULLE, MD

CONTACT

[email protected]

04 67 33 52 34 ext. +33

About this study

Current environmental changes are influencing the epidemiology of zoonoses, which account for over 75% of emerging infections, with the Mediterranean region being a high-risk area. The proposed study focuses on occupational zoonoses, that is, those that can be contracted in the workplace, through direct contact with animals or exposure to their environment. Some of these zoonoses are recognized and compensable as occupational diseases (OD), while for others, the onus is on the employee to prove the origin of the contamination. The advantages of studying this population are threefold: i) to document occupational risk and improve management and prevention practices in this context, ii) to use this sentinel population - when many of these zoonoses are emerging - to anticipate risks for the less-exposed general population, iii) in the event of the discovery of a positive serology for an infectious agent considered non-circulating in the Occitanie region, to improve the management of symptomatic patients by raising awareness of differential diagnosis. For the purposes of this study, the zoonoses recognized as occupational diseases are: Mediterranean spotted fever, Lyme borreliosis, tularemia, Q fever, brucellosis, psittacosis, hepatitis E and leptospirosis. Although not recognized as occupational diseases, leishmaniasis, hantaviruses, dengue fever, zika, chikungunya, West Nile virus, Usutu, Toscana, Crimean-Congo hemorrhagic fever and tick-borne encephalitis are of particular interest to workers exposed to these diseases, and are also included in the study.

Few data are currently available on the actual rate of circulation of these pathogens in the population of occupationally exposed workers, and none in Occitanie. These outdoor workers also represent a sentinel population, due to their increased exposure, so obtaining precise seroprevalence data in these groups would enable the researchers to anticipate the emergence of these pathogens in the general population in the near future, and to diagnose them individually.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or over
  • Consultant in an infectious diseases department
  • Have given written consent to participate in the study
  • Working for the City or Metropolis of Montpellier in the Zoo, Espaces Vert or Ecolothèque departments.

Exclusion criteria

  • - Pregnant and breast-feeding women
  • Persons benefiting from legal protection measures (guardianship, curatorship, safeguard of justice)
  • Participants who are not fluent in French and who do not have a support person capable of reading French.
  • Persons unable to express their consent.
  • Persons participating in another research project with an exclusion period still in progress.
  • Persons not affiliated to a social security scheme or not benefiting from such a scheme.

Treatment and study plan

Peripheral venous blood sample

Other

Peripheral venous blood sampling for IgG serology against leishmaniasis, leptospirosis, brucellosis, Q fever, rickettsiosis, tularemia, psittacosis, Lyme disease, tick-borne encephalitis, hantavirus, hepatitis E virus, dengue virus, Zika virus, Chikungunya virus, West Nile virus, Usutu virus, Toscana virus, Crimean-Congo hemorrhagic fever virus.

Primary outcomes

  1. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Leishmaniasis,

    Time frame: Baseline

    prevalence (in percentage) of pathogen IgG positivity against : Leishmaniasis,

  2. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Leptospirosis,

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Leptospirosis,

  3. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Brucellosis

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Brucellosis

  4. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Q fever

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Q fever

  5. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Rickettsiosis

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Rickettsiosis,

  6. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Tularemia

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Tularemia

  7. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Psittacosis

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Psittacosis

  8. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Lyme disease,

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Lyme disease,

  9. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Tick-borne encephalitis

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Tick-borne encephalitis

  10. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Hantavirus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Hantavirus

  11. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Hepatitis E virus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Hepatitis E virus

  12. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Dengue virus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Dengue virus

  13. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Zika virus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Zika virus

  14. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Chikungunya virus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Chikungunya virus

  15. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). West-Nile virus,

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : West-Nile virus,

  16. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). usutu virus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Usutu virus

  17. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Toscana virus

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Toscana virus

  18. Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Crimean-Congo haemorrhagic fever virus.

    Time frame: Baseline

    prevalence of pathogen IgG positivity against : Crimean-Congo haemorrhagic fever virus.

Secondary outcomes

  1. Determine the factors associated with seropositivity to these diseases. socio-demographic criteria

    Time frame: Baseline

    OR of logistic regression of univariate model between serologies and socio-demographic criteria (age, sex, profession)

  2. Determine the factors associated with seropositivity to these diseases. travel to endemic areas

    Time frame: Baseline

    OR of the logistic regression of the univariate model between serologies and travel to endemic areas for these diseases

  3. Determine the factors associated with seropositivity to these diseases. occupational exposure

    Time frame: Baseline

    OR of the logistic regression of the univariate model between serologies and occupational exposure to these pathologies

  4. Determine the factors associated with seropositivity to these diseases. exposure in private activities

    Time frame: Baseline

    OR of the logistic regression of the univariate model between serologies and exposure in private activities, including the importance of contact with transmission vectors,

  5. Determine the factors associated with seropositivity to these diseases. use of mosquito protection

    Time frame: Baseline

    OR of the logistic regression of the univariate model between serologies and use of mosquito protection,

  6. Determine the factors associated with seropositivity to these diseases.history of transfusion or transplant

    Time frame: Baseline

    OR of the logistic regression of the univariate model between serologies and history of transfusion or transplant

  7. Determine the factors associated with seropositivity to these diseases. comparison of the linear models

    Time frame: Baseline

    AOR of the multivariate logistic regression with the best AIC among all the models tested

  8. Estimating vaccination coverage against leptospirosis in the workplace

    Time frame: Baseline

    prevalence (in percentage) of professional vaccinations for leptospirosis

  9. Estimating vaccination coverage against rabies in the workplace

    Time frame: Baseline

    prevalence (in percentage) of professional vaccinations for rabies

  10. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Dengue virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Dengue virus

  11. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Dengue virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Dengue virus

  12. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Zika virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Zika virus

  13. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Zika virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Zika virus

  14. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Chikungunya virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Chikungunya virus

  15. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Chikungunya virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Chikungunya virus

  16. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. West-Nile virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for West-Nile virus

  17. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. West-Nile virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for West-Nile virus

  18. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Usutu virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Usutu virus

  19. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Usutu virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Usutu virus

  20. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Toscana virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Toscana virus

  21. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Toscana virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Toscana virus

  22. Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Crimean-Congo haemorrhagic fever virus

    Time frame: Baseline

    Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Crimean-Congo haemorrhagic fever virus

  23. Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Crimean-Congo haemorrhagic fever virus

    Time frame: Baseline

    Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Crimean-Congo haemorrhagic fever virus

Study contacts

Contact information is provided by the study sponsor or research team.

CHARLOTTE BOULLE, MD

CONTACT

[email protected]

04 67 33 52 34 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • TransVIHMI UM, IRD UMI233, Inserm U1175
  • UMR 1058 Pathogenesis & Control of Chronic & Emerging Infections PCCEI

Registry information

Official study title

Seroprevalence of Zoonotic and Arboviral Emerging Infections in Exposed Agents from the City of Montpellier: a Transversal Study.

Acronym: SEZAM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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