Dynamics of AMR Spread, Persistence and Evolution Between... | NCT06262009

Studies
Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment

NCT06262009

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

525Estimated

Phase

Not provided

Conditions

Antibiotic Resistant Strain
Transmission, Close-Contact

Interventions

human faecal collection
ancillary study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A02282-43	Other Identifier	IDRCB

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2025Actual

Primary Completion Date

Sep 2028Estimated

Completion Date

Mar 2029Estimated

First Submitted Date

Feb 8, 2024

First Submission Date that Met QC Criteria

Feb 8, 2024

First Posted Date

Feb 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

525Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
household		House Members (adults and minors) from 175 households owning a dog	Other: human faecal collection Other: ancillary study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
human faecal collection	Other	collecting stools 6 times over a 90 days period and complete a questionnaire at the same times: D1, D7, D15, D30, D60 and D90	household

Outcomes Module

Primary Outcomes

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	mathematical models combining all the data (epidemiological, bacteriological, genomic, sociological) gathered in the project	over the 90 days follow up

Secondary Outcomes

Measure	Description	Time Frame
Rates of AMR acquisitions in one or several housekeepers		over the 90 days follow up
A list in nature of changes in dog microbiota		over the 90 days follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The healthy volunteers (dog owners) will be recruited at a single recruitment centre, which is the National Veterinary School (Maisons-Alfort).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Yves Madec, PHD	Contact	06 85 08 93 30	+33	Jean-Yves.MADEC@anses.fr

Overall Officials

Name	Affiliation	Role
Jean-Yves Madec, PHD	ANSES	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the National Veterinary School Alfort	Recruiting	Maisons-Alfort		94700	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided