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

Antibiotic Resistant Strain Clinical Trial

— Dyaspeo  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262009
• Other study ID #: APHP220101
• Secondary ID: 2023-A02282-43
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Yves Madec, PHD
• Phone: 06 85 08 93 30
• Email: Jean-Yves.MADEC[@]anses.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 525
• Est. completion date: March 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Strain

Intervention

Other:
• human faecal collection
collecting stools 6 times over a 90 days period and complete a questionnaire at the same times: D1, D7, D15, D30, D60 and D90
• ancillary study
interviews and/or ethnographic observations for 50 volunteers

Locations

Country	Name	City	State
France	the National Veterinary School Alfort	Maisons-Alfort

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of AMR acquisitions in one or several housekeepers		over the 90 days follow up
Secondary	A list in nature of changes in dog microbiota		over the 90 days follow up
Secondary	A list in magnitude of changes in dog microbiota		over the 90 days follow up
Secondary	A list in nature of changes in housekeepers microbiota		over the 90 days follow up
Secondary	A list in magnitude of changes in housekeepers microbiota		over the 90 days follow up
Secondary	explore unknown parameters of AMR colonization in dogs under various antibiotic exposures		over the 90 days follow up
Secondary	the generation of a list of sociological factors and potential at-risk practices relevant in the transmission of AMR from dogs to housekeepers		during semi-directive interviews and/or observational periods