- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07898930
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination (FARMHAND)
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination - FARMHAND
Antimicrobial resistance is a major public health issue. Methicillin resistance in Staphylococcus aureus (MRSA) is one of the indicators that is monitored particularly closely. In animals, pig farms, among others, have been identified as reservoirs of MRSA, with a risk of transmission to humans, particularly to individuals in direct contact with livestock. In France, the prevalence of MRSA in pig farms has increased markedly in recent years.
While cross-species transmission between pigs and humans in professional settings is well-documented, the temporal dynamics, the actual incidence of acquisition, and the associated determinants remain insufficiently characterized in France.
Adopting a "One Health" approach, this project aims to gain a better understanding of the mechanisms by which MRSA spreads between animal and human subpopulations and to incorporate these insights into a mathematical modeling framework.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The participants in this project will be farmers representing 20 different pig farms, the majority of which will be located in Brittany-a region recognized as the leading pork-producing area in France.
Participants will be asked to provide two types of samples, only one of which will contain personally identifiable data.
- Nasal swabs: Participants in the study will be asked to perform a self-administered nasal swab once a month, at approximately the same time each month. This method was selected because it has demonstrated an acceptable level of participant compliance, as well as satisfactory validity for detecting S. aureus carriage in humans.
- Dust samples: Participants will be asked to collect dust samples from the production floor-specifically in the room within the finishing facility that houses the oldest animals-by wiping surfaces with a small cloth. This method was chosen because dust in livestock-rearing environments has been identified as a reliable indicator of MRSA carriage status in pigs.
These successive samplings will be carried out over time in order to analyze carriage dynamics and estimate epidemiological parameters of interest. A modeling component will be incorporated to make use of the data collected.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Fanny BEGUIER
- Telefonnummer: +33 0296018165
- E-post: recherche.clinique@armorsante.bzh
Studer Kontakt Backup
- Navn: Marie-Pierre DUBAN
- E-post: recherche.clinique@armorsante.bzh
Studiesteder
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Ploufragan, Frankrike, 22440
- Anses Ploufragan - Plouzané - Niort, site de Ploufragan
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Ta kontakt med:
- Claire CHAUVIN, Dr
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Saint-Brieuc, Frankrike, 22000
- Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier, site de Saint-Brieuc
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Ta kontakt med:
- Clarisse DUPIN, Dr
- E-post: clarisse.dupin@armorsante.bzh
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18 years of age or older,
- Work full-time as a pig farmer on the participating farm,
- Have regular contact with the animals, defined as at least 4 days per week,
- Be willing to participate in the study and sign an informed consent form,
- Agree to perform monthly self-administered nasal swab sampling and to provide data via a questionnaire.
Exclusion Criteria:
- Refusal to participate or inability to provide informed consent,
- Inability to perform monthly self-administered nasal swabs in accordance with the protocol,
- Employment on a part-time basis, or status as an intern or apprentice within the operation,
- No inclusion of persons targeted by Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g., minors, legally protected adults, etc.)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Farmers representing 20 different pig farms
|
Participants will be asked to provide two types of samples, only one of which will contain personally identifiable information.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To estimate the prevalence of nasal carriage of MRSA among pig farmers during the study period.
Tidsramme: From enrollment to the end of the study : 24 months
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The primary outcome measure is the prevalence of nasal carriage of MRSA among pig farmers during the study period, as determined by microbiological detection from self-collected nasal swabs. |
From enrollment to the end of the study : 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Describe the temporal dynamics of nasal carriage of Staphylococcus aureus among pig farmers and within farms.
Tidsramme: From enrollment to the end of the study : 24 months
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The prevalence of nasal carriage of MSSA among pig farmers. |
From enrollment to the end of the study : 24 months
|
|
Estimate the incidence of acquisition and clearance of MRSA and MSSA among pig farmers and within farms, based on repeated longitudinal measurements.
Tidsramme: From enrollment to the end of the study : 24 months
|
The incidence of acquisition and clearance of MRSA and MSSA among pig farmers, estimated from repeated longitudinal measurements of nasal carriage. |
From enrollment to the end of the study : 24 months
|
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Identify factors associated with the carriage and acquisition of MRSA among pig farmers.
Tidsramme: From enrollment to the end of the study : 24 months
|
The prevalence and incidence of MSSA and MRSA within the pig farm environment. |
From enrollment to the end of the study : 24 months
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026_CHSB_FARMHAND
- 2026-A01235-46 (Annen identifikator: ID RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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