Actively Recruiting

All Genders
Healthy Volunteers
NCT05798364

Household Transmission Dynamics of Multidrug Resistant Enterobacterales

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-06-04

507

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The HOME study will prospectively follow a cohort of Multi-Drug Resistant Enterobacterales (MDR-E) carriers after hospital discharge, and their related household members over a 3-month period. The main objective is to estimate the rate of confirmed transmissions of MDR-E from the index cases to related household members, and identify predictors associated with transmission. Transmission will be confirmed by comparing genomic analysis of the MDR-E strains isolated both in the index patient and his/her household members, based on the number of Single nucleotide polymorphisms (SNPs) differences between nearby genomes by Variant Calling. Multifactorial processes involved in MDR-E transmission in households will be explored with stochastic individual-based modelling. The parameterized model will be used to simulate and assess different strategies of control of MDR-E emergence and transmission to households. The impact of modifying patterns of human-contacts, promote hygiene and control barriers (decontamination of objects or surfaces, variations in antibiotic use, reinforcement of hand hygiene) will be assessed.

CONDITIONS

Official Title

Household Transmission Dynamics of Multidrug Resistant Enterobacterales

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (18 years or older) hospitalized in participating hospitals
  • Positive for MDR-E fecal carriage during hospital stay
  • No documented MDR-E fecal carriage in the 12 months before current hospitalization
  • Living regularly with at least two household members who agree to participate
  • Planning to live in Ile de France for the next three months
  • Household members of any age living in the same household during the 3 months after inclusion who agree to participate
  • Household members planning to live in Ile de France for the next three months
Not Eligible

You will not qualify if you...

  • Lack of agreement to participate and to use clinical data
  • Persons under legal protection (guardianship)
  • Persons deprived of liberty by judicial order
  • Persons undergoing psychiatric care
  • Lack of social security affiliation
  • Index patients negative for MDR-E fecal carriage before or on day of discharge

AI-Screening

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Trial Site Locations

Total: 1 location

1

Bichat Hospital

Paris, Île-de-France Region, France, 75018

Actively Recruiting

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Research Team

K

Kernéis Solen, MD, PhD

CONTACT

A

Armand-Lefevre Laurence, Pharm. D., PhD.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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