CClinicalTrials.gg
Not yet recruitingNCT06859619SEZAMUpdated Mar 5, 2025

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

An interventional study of Peripheral venous blood sample in Leishmaniasis, Leptospirosis and Brucellosis, sponsored by University Hospital, Montpellier. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
183
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
183 participants (estimated)

Study arms

  • 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

Interventions

  • OtherPeripheral 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.

05

What researchers measure

Primary outcomes

  1. 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,

    Time frame: Baseline

  2. 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,

    Time frame: Baseline

  3. 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

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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,

    Time frame: Baseline

  6. 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

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. 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,

    Time frame: Baseline

  9. 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

    Time frame: Baseline

  10. 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

    Time frame: Baseline

  11. 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

    Time frame: Baseline

  12. 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

    Time frame: Baseline

  13. 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

    Time frame: Baseline

  14. 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

    Time frame: Baseline

  15. 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,

    Time frame: Baseline

  16. 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

    Time frame: Baseline

  17. 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

    Time frame: Baseline

  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.

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

    Time frame: Baseline

Secondary outcomes

  1. 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)

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. 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

    Time frame: Baseline

  4. 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,

    Time frame: Baseline

  5. 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,

    Time frame: Baseline

  6. 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

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. Estimating vaccination coverage against leptospirosis in the workplace

    prevalence (in percentage) of professional vaccinations for leptospirosis

    Time frame: Baseline

  9. Estimating vaccination coverage against rabies in the workplace

    prevalence (in percentage) of professional vaccinations for rabies

    Time frame: Baseline

  10. 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

    Time frame: Baseline

  11. 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

    Time frame: Baseline

  12. 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

    Time frame: Baseline

  13. 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

    Time frame: Baseline

  14. 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

    Time frame: Baseline

  15. 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

    Time frame: Baseline

  16. 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

    Time frame: Baseline

  17. 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

    Time frame: Baseline

  18. 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

    Time frame: Baseline

  19. 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

    Time frame: Baseline

  20. 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

    Time frame: Baseline

  21. 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

    Time frame: Baseline

  22. 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

    Time frame: Baseline

  23. 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

    Time frame: Baseline

06

Study locations

1 site
  • University Hospital Of Montpellier
    Montpellier, Herault 34295, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06859619
Lead sponsor
University Hospital, Montpellier
Collaborators
TransVIHMI UM, IRD UMI233, Inserm U1175, UMR 1058 Pathogenesis & Control of Chronic & Emerging Infections PCCEI
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
Mar 3, 2025 (estimated)
Primary completion
Oct 3, 2025 (estimated)
Completion
Oct 3, 2025 (estimated)
Last update
Mar 5, 2025

Study contacts

CHARLOTTE BOULLE, MD
Contact
c-boulle@chu-montpellier.fr
04 67 33 52 34 ext. +33
CHARLOTTE BOULLE, MD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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