Clinical trial NCT06859619: Serological Measurement of Montpellier Professionals' Contacts with Infectious Agents Responsible for Animal-borne Diseases
Official title: Seroprevalence of Zoonotic and Arboviral Emerging Infections in Exposed Agents from the City of Montpellier: a Transversal Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Leishmaniasis
Leptospirosis
Brucellosis
Q Fever
Rickettsiosis
Tularemia
Psittacosis
Lyme Disease
Tick-borne Encephalitis
Hantaviral Infection Nos
Hepatitis E
Dengue Virus
Zika Virus
Chikungunya Virus Infection
West Nile Virus
Usutu Virus
Toscana Virus
Crimean-Congo Haemorrhagic Fever Virus
Keywords: Leishmaniasis,
Leptospirosis
Brucellosis
Zika virus
Q fever, Rickettsiosis
Lyme disease
Tick-borne encephaliti
Hantavirus
Hepatitis E virus
Dengue virus
Chikungunya virus
West-Nile virus
Usutu virus
Toscana virus
Tularemia
Psittacosis
Crimean-Congo haemorrhagic fever virus
epidemiology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: TransVIHMI UM, IRD UMI233, Inserm U1175
name: UMR 1058 Pathogenesis & Control of Chronic & Emerging Infections PCCEI
First posted: 2025-03-05
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cross-sectional study with minimal risk and constraints
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Leishmaniasis,
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Leptospirosis,
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Brucellosis
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Q fever
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Rickettsiosis
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Tularemia
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Psittacosis
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Lyme disease,
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Tick-borne encephalitis
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Hantavirus
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Hepatitis E virus
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Dengue virus
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). Zika virus
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Chikungunya virus
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). West-Nile virus,
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies). usutu virus
timeFrame: Baseline
measure: Estimate seroprevalences of the zoonoses in populations exposed to wildlife by zoo staff and to various vectors (ticks, mosquitoes, sandflies).Toscana virus
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: Determine the factors associated with seropositivity to these diseases. socio-demographic criteria
timeFrame: Baseline
measure: Determine the factors associated with seropositivity to these diseases. travel to endemic areas
timeFrame: Baseline
measure: Determine the factors associated with seropositivity to these diseases. occupational exposure
timeFrame: Baseline
measure: Determine the factors associated with seropositivity to these diseases. exposure in private activities
timeFrame: Baseline
measure: Determine the factors associated with seropositivity to these diseases. use of mosquito protection
timeFrame: Baseline
measure: Determine the factors associated with seropositivity to these diseases.history of transfusion or transplant
timeFrame: Baseline
measure: Determine the factors associated with seropositivity to these diseases. comparison of the linear models
timeFrame: Baseline
measure: Estimating vaccination coverage against leptospirosis in the workplace
timeFrame: Baseline
measure: Estimating vaccination coverage against rabies in the workplace
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Dengue virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Dengue virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Zika virus
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Zika virus
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Chikungunya virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Chikungunya virus
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. West-Nile virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. West-Nile virus
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Usutu virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Usutu virus
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Toscana virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Toscana virus
timeFrame: Baseline
measure: Determine the sensitivity of DBS (dried blood spot) serum neutralization for viral serologies. Crimean-Congo haemorrhagic fever virus
timeFrame: Baseline
measure: Determine the specificity of DBS (dried blood spot) serum neutralization for viral serologies. Crimean-Congo haemorrhagic fever virus
timeFrame: Baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Of Montpellier
state: Herault
Study officials:
affiliation: University Hospital, Montpellier
name: CHARLOTTE BOULLE, MD
role: PRINCIPAL_INVESTIGATOR
References: