- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fanny BEGUIER
- Numéro de téléphone: +33 0296018165
- E-mail: recherche.clinique@armorsante.bzh
Sauvegarde des contacts de l'étude
- Nom: Marie-Pierre DUBAN
- E-mail: recherche.clinique@armorsante.bzh
Lieux d'étude
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Ploufragan, France, 22440
- Anses Ploufragan - Plouzané - Niort, site de Ploufragan
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Contact:
- Claire CHAUVIN, Dr
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Saint-Brieuc, France, 22000
- Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier, site de Saint-Brieuc
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Contact:
- Clarisse DUPIN, Dr
- E-mail: clarisse.dupin@armorsante.bzh
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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To estimate the prevalence of nasal carriage of MRSA among pig farmers during the study period.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Describe the temporal dynamics of nasal carriage of Staphylococcus aureus among pig farmers and within farms.
Délai: From enrollment to the end of the study : 24 months
|
The prevalence of nasal carriage of MSSA among pig farmers. |
From enrollment to the end of the study : 24 months
|
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Estimate the incidence of acquisition and clearance of MRSA and MSSA among pig farmers and within farms, based on repeated longitudinal measurements.
Délai: 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.
Délai: 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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026_CHSB_FARMHAND
- 2026-A01235-46 (Autre identifiant: ID RCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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