LeishmaniasisSEZAMNCT06859619
Serological Measurement of Montpellier Professionals' Contacts with Infectious Agents Responsible for Animal-borne Diseases
A study testing Peripheral venous blood sample in people with Leishmaniasis and Leptospirosis, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leishmaniasis, Leptospirosis, Brucellosis
- What is being tested?
- Peripheral venous blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2025to 3 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Of Montpellier
Montpellier, herault, 34295
CHARLOTTE BOULLE, MD, 04 67 33 52 34 ext. +33, c-boulle@chu-montpellier.fr
About this study
Official title: 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.
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.
- Conditions
- Leishmaniasis, Leptospirosis, Brucellosis, Q Fever, Rickettsiosis, Tularemia
- Being tested
- Peripheral venous blood sample
- 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
- Medical subject headings
- Leishmaniasis, Leptospirosis, Brucellosis, Q Fever, Rickettsia Infections, Tularemia, Psittacosis, Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral venous blood sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| City of Montpellier employees working at the Zoo, the Ecolothèque and the Green Spaces Department | Experimental | 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 Receives: Other: Peripheral venous blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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,
Measured: 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
Measured: 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
Measured: 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,
Measured: 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
Measured: 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
Measured: 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,
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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,
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline
Secondary outcomes (23)
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)
Measured: 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
Measured: 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
Measured: 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,
Measured: 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,
Measured: 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
Measured: 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
Measured: Baseline
Estimating vaccination coverage against leptospirosis in the workplace
prevalence (in percentage) of professional vaccinations for leptospirosis
Measured: Baseline
Estimating vaccination coverage against rabies in the workplace
prevalence (in percentage) of professional vaccinations for rabies
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start3 Mar 2025 (estimated)
- Primary completion3 Oct 2025 (estimated)
- Study completion3 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cross-sectional study with minimal risk and constraints
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- TransVIHMI UM, IRD UMI233, Inserm U1175, UMR 1058 Pathogenesis & Control of Chronic & Emerging Infections PCCEI
- Responsible party
- Sponsor
- Investigators
- CHARLOTTE BOULLE, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859619
- Sponsor's protocol ID
- RECHMPL24_0384
- Acronym
- SEZAM
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided