Household Transmission Dynamics of Multidrug Resistant Enterobacterales

Study acronym: HOME
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated June 4, 2024 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jun 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jan 30, 2024 to May 2026
    • Study sites: 0 to 1
    • Study completion date: Feb 15, 2024 to Sep 2026
    • Start date changed from estimate of Apr 1, 2023 to May 19, 2023
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05798364
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)		 Adults Patients, With Fecal Carriage of Multi-Drug Resistant Enterobacterales (MDR-E)
Enrollment 507 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov