- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06262009
Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment (Dyaspeo)
Study Overview
Status
Intervention / Treatment
Detailed Description
Antimicrobial resistance (AMR) is a global and multifaceted public health problem. Advanced knowledge on AMR has demonstrated that it not only affects humans but is also widely distributed across animals and the environment. A major cause of the AMR burden refers to the capability of AMR to transmit within and between individuals, including between humans and animals. Leading examples of internationally distributed AMR bacteria are Enterobacterial disseminating resistances to extended-spectrum cephalosporins (ESC-E) and carbapenems (CP-E). Yet, the magnitude and pathways of their cross-sectorial transfers are poorly understood.
There is a great concern that humans in contact with animals be at risk of ESC-E/CP-E acquisition. Whereas an increase in ESC-E carriage in farmers in contact with their food-producing animals was reported, AMR transmission to humans through direct contacts with companion animals has been much less studied. Owing the close relationships between pets and owners, and the fact that 50% of households host a dog or a cat in France, the hypothesis of pet ownership being a risk for humans to acquire ESC-E/CP-E appears strongly relevant. The DYASPEO project will investigate this question through a combination of several approaches from field to laboratory studies, and including epidemiology, ecology, molecular and population genomics, studies on intestinal microbiota, modelling and social sciences.
We hypothesize that the interface between humans and companion animals plays a significant role in the transfer of ESC-E/CP-E. This hypothesis is corroborated (i) by recent data in France showing that antibiotic exposure of companion animals is still increasing contrary to all other animal host (e.g. food-producing animals) and (ii) by a recent study from the consortium demonstrating a high AMR prevalence in dogs getting back home after hospitalization.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jean-Yves Madec, PHD
- Phone Number: +33 06 85 08 93 30
- Email: jean-yves.madec@anses.fr
Study Locations
-
-
-
Maisons-Alfort, France, 94700
- Recruiting
- the National Veterinary School Alfort
-
Contact:
- Jean-Yves Madec, PHD
- Phone Number: +33 06 85 08 93 30
- Email: jean-yves.madec@anses.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult or child planning to live in the same household as his/her dog during the three months following inclusion.
- Planning to live in the same habitat in the next three months following inclusion (except for holidays).
- Written consent of all adults and of at least one of the two parents for minors under parental authority. A different information note will be elaborated for each age category (6-10 yr-old, 10-15 yr-old and 16-18 yr-old).
- Owning a dog recorded for a surgery at the National Veterinary School
Exclusion Criteria:
- Lack of signed informed consent
- Subject in alternating custody
- Subject under legal protection (guardianship)
- Subject deprived of liberty under judicial constraint
- Subject undergoing psychiatric care
- Lack of affiliation to a social security scheme
- Volunteers who do not speak/write French
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
household
House Members (adults and minors) from 175 households owning a dog
|
collecting stools 6 times over a 90 days period and complete a questionnaire at the same times: D1, D7, D15, D30, D60 and D90
interviews and/or ethnographic observations for 50 volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
generation of a list of priorities for future prevention and control strategies to mitigate antimicrobial resistance (AMR) transmission between companion animals and humans
Time Frame: over the 90 days follow up
|
mathematical models combining all the data (epidemiological, bacteriological, genomic, sociological) gathered in the project
|
over the 90 days follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rates of AMR acquisitions in one or several housekeepers
Time Frame: over the 90 days follow up
|
over the 90 days follow up
|
|
A list in nature of changes in dog microbiota
Time Frame: over the 90 days follow up
|
over the 90 days follow up
|
|
A list in magnitude of changes in dog microbiota
Time Frame: over the 90 days follow up
|
over the 90 days follow up
|
|
A list in nature of changes in housekeepers microbiota
Time Frame: over the 90 days follow up
|
over the 90 days follow up
|
|
A list in magnitude of changes in housekeepers microbiota
Time Frame: over the 90 days follow up
|
over the 90 days follow up
|
|
explore unknown parameters of AMR colonization in dogs under various antibiotic exposures
Time Frame: over the 90 days follow up
|
over the 90 days follow up
|
|
the generation of a list of sociological factors and potential at-risk practices relevant in the transmission of AMR from dogs to housekeepers
Time Frame: during semi-directive interviews and/or observational periods
|
during semi-directive interviews and/or observational periods
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Yves Madec, PHD, ANSES
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP220101
- 2023-A02282-43 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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