- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Fanny BEGUIER
- 전화번호: +33 0296018165
- 이메일: recherche.clinique@armorsante.bzh
연구 연락처 백업
- 이름: Marie-Pierre DUBAN
- 이메일: recherche.clinique@armorsante.bzh
연구 장소
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Ploufragan, 프랑스, 22440
- Anses Ploufragan - Plouzané - Niort, site de Ploufragan
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연락하다:
- Claire CHAUVIN, Dr
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Saint-Brieuc, 프랑스, 22000
- Centre Hospitalier de Saint-Brieuc - Paimpol - Tréguier, site de Saint-Brieuc
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연락하다:
- Clarisse DUPIN, Dr
- 이메일: clarisse.dupin@armorsante.bzh
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To estimate the prevalence of nasal carriage of MRSA among pig farmers during the study period.
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Describe the temporal dynamics of nasal carriage of Staphylococcus aureus among pig farmers and within farms.
기간: 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
|
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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.
기간: 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.
기간: From enrollment to the end of the study : 24 months
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The prevalence and incidence of MSSA and MRSA within the pig farm environment. |
From enrollment to the end of the study : 24 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026_CHSB_FARMHAND
- 2026-A01235-46 (기타 식별자: ID RCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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