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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leishmaniasis; Lyme Disease; Brucellosis; Hepatitis E; Dengue Virus; Zika Virus; West Nile Virus; Leptospirosis; Tularemia; Chikungunya Virus Infection; Tick-borne Encephalitis; Q Fever; Rickettsiosis; Psittacosis; Hantaviral Infection Nos; Usutu Virus; Toscana Virus; Crimean-Congo Haemorrhagic Fever Virus
• Intervention / Treatment: Other: Peripheral venous blood sample

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 183
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHARLOTTE BOULLE, MD; Phone Number: +33 04 67 33 52 34; Email: c-boulle@chu-montpellier.fr

Study Locations

• France
  • Herault
    • Montpellier, Herault, France, 34295
      • University Hospital of Montpellier
      • Contact: CHARLOTTE BOULLE, MD; Phone Number: +33 04 67 33 52 34; Email: c-boulle@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: City of Montpellier employees working at the Zoo, the Ecolothèque and the Green Spaces Department; City of Montpellier employees working at the Zoo, Ecolotheque or green spaces exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies) in the Occitanie region	Other: Peripheral venous blood sample; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Leishmaniasis,	prevalence (in percentage) of pathogen IgG positivity against : Leishmaniasis,	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Leptospirosis,	prevalence of pathogen IgG positivity against : Leptospirosis,	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Brucellosis	prevalence of pathogen IgG positivity against : Brucellosis	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Q fever	prevalence of pathogen IgG positivity against : Q fever	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Rickettsiosis	prevalence of pathogen IgG positivity against : Rickettsiosis,	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Tularemia	prevalence of pathogen IgG positivity against : Tularemia	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Psittacosis	prevalence of pathogen IgG positivity against : Psittacosis	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Lyme disease,	prevalence of pathogen IgG positivity against : Lyme disease,	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Tick-borne encephalitis	prevalence of pathogen IgG positivity against : Tick-borne encephalitis	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Hantavirus	prevalence of pathogen IgG positivity against : Hantavirus	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Hepatitis E virus	prevalence of pathogen IgG positivity against : Hepatitis E virus	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Dengue virus	prevalence of pathogen IgG positivity against : Dengue virus	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Zika virus	prevalence of pathogen IgG positivity against : Zika virus	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Chikungunya virus	prevalence of pathogen IgG positivity against : Chikungunya virus	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). West-Nile virus,	prevalence of pathogen IgG positivity against : West-Nile virus,	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). usutu virus	prevalence of pathogen IgG positivity against : Usutu virus	Baseline
Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Toscana virus	prevalence of pathogen IgG positivity against : Toscana virus	Baseline
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.	prevalence of pathogen IgG positivity against : Crimean-Congo haemorrhagic fever virus.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the factors associated with seropositivity to these diseases. socio-demographic criteria	OR of logistic regression of univariate model between serologies and socio-demographic criteria (age, sex, profession)	Baseline
Determine the factors associated with seropositivity to these diseases. travel to endemic areas	OR of the logistic regression of the univariate model between serologies and travel to endemic areas for these diseases	Baseline
Determine the factors associated with seropositivity to these diseases. occupational exposure	OR of the logistic regression of the univariate model between serologies and occupational exposure to these pathologies	Baseline
Determine the factors associated with seropositivity to these diseases. exposure in private activities	OR of the logistic regression of the univariate model between serologies and exposure in private activities, including the importance of contact with transmission vectors,	Baseline
Determine the factors associated with seropositivity to these diseases. use of mosquito protection	OR of the logistic regression of the univariate model between serologies and use of mosquito protection,	Baseline
Determine the factors associated with seropositivity to these diseases.history of transfusion or transplant	OR of the logistic regression of the univariate model between serologies and history of transfusion or transplant	Baseline
Determine the factors associated with seropositivity to these diseases. comparison of the linear models	AOR of the multivariate logistic regression with the best AIC among all the models tested	Baseline
Estimating vaccination coverage against leptospirosis in the workplace	prevalence (in percentage) of professional vaccinations for leptospirosis	Baseline
Estimating vaccination coverage against rabies in the workplace	prevalence (in percentage) of professional vaccinations for rabies	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Dengue virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Dengue virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Dengue virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Dengue virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Zika virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Zika virus	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Zika virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Zika virus	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Chikungunya virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Chikungunya virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Chikungunya virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Chikungunya virus	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. West-Nile virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for West-Nile virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. West-Nile virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for West-Nile virus	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Usutu virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Usutu virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Usutu virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Usutu virus	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Toscana virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Toscana virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Toscana virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Toscana virus	Baseline
Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Crimean-Congo haemorrhagic fever virus	Determine the sensitivity (in percentage) of DBS (dried blood spot) seroneutralization for Crimean-Congo haemorrhagic fever virus	Baseline
Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Crimean-Congo haemorrhagic fever virus	Determine the specificity (in percentage) of DBS (dried blood spot) seroneutralization for Crimean-Congo haemorrhagic fever virus	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: TransVIHMI UM, IRD UMI233, Inserm U1175; UMR 1058 Pathogenesis & Control of Chronic & Emerging Infections PCCEI
• Investigators: Principal Investigator: CHARLOTTE BOULLE, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Estimated): March 3, 2025
• Primary Completion (Estimated): October 3, 2025
• Study Completion (Estimated): October 3, 2025

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: epidemiology; Zika virus; Lyme disease; Hepatitis E virus; Dengue virus; Chikungunya virus; Leishmaniasis,; Hantavirus; Leptospirosis; Brucellosis; Q fever, Rickettsiosis; Tick-borne encephaliti; West-Nile virus; Usutu virus; Toscana virus; Tularemia; Psittacosis; Crimean-Congo haemorrhagic fever virus
• Additional Relevant MeSH Terms: Infectious Encephalitis; Vector Borne Diseases; Neuroinflammatory Diseases; Mosquito-Borne Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Liver Diseases; Hepatitis, Viral, Human; Protozoan Infections; Parasitic Diseases; Skin Diseases; Pneumonia; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Skin Diseases, Infectious; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Body Temperature Changes; Heat Stress Disorders; Skin Diseases, Parasitic; Chlamydiaceae Infections; Pneumonia, Bacterial; Alphavirus Infections; Togaviridae Infections; Rickettsiaceae Infections; Encephalitis, Arbovirus; Euglenozoa Infections; Bunyaviridae Infections; Chlamydia Infections; Chlamydophila Infections; Hyperthermia; Zika Virus Infection; Hepatitis; Dengue; Lyme Disease; Infections; Communicable Diseases; Virus Diseases; Encephalitis; Fever; Brucellosis; Chikungunya Fever; Leishmaniasis; Hemorrhagic Fevers, Viral; Hemorrhagic Fever, Crimean; Encephalitis, Tick-Borne; Hepatitis E; Leptospirosis; Weil Disease; Tularemia; Q Fever; Rickettsia Infections; Psittacosis; Chlamydial Pneumonia
• Other Study ID Numbers: RECHMPL24_0384

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No