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Recruiting NCT05871476

Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals

No phase Interventional Antibiotic Resistant Infection Carbapenem-Resistant Enterobacteriaceae Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hospital Cohort Care Intervention at the hospital, , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention.
Who it may be relevant to
Registry conditions: Antibiotic Resistant Infection, Carbapenem-Resistant Enterobacteriaceae Infection. Basic parameters: up to 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals

Overview

Carbapenem resistant Enterobacteriaceae (CRE) colonization of patients discharged from hospitals is a source of transmission to the community. In a cluster randomized controlled trial the effect of a bundle of interventions will be assessed on CRE transmission from CRE+ index patient discharged from hospital to HouseHold (HH) members. The districts in two provinces will be randomized to intervention or control. An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic (AB) use. The effect will be evaluated on CRE transmission between HH members, livestock and environment through consecutive CRE screening using fecal and hospital effluent samples cultured on carbapenem selective media. Knowledge, Attitudes, Practice surveys with smartphones will assess health seeking, AB use and hygiene adherence, hence detecting the effect of interventions. If transmission of CRE +/- Colistin Resistant Enterobacteriaceae (CoRE, common among livestocks) is detected the source will be investigated including livestock and food, targeted information will be given and evaluated. In hospitals the effect of cohort care will be assessed on CRE acquisition, hospital acquired infection, treatment outcome, costeffectiveness and contamination in sewage water. Mechanisms of resistance, relatedness of CRE isolates in different One Health departments, and rate of CRE transmission from humans to animals and vice versa, will be assessed through Whole Genome Sequencing (WGS).

Interventions

  • Behavioral Hospital Cohort Care Intervention at the hospital
    There will be 3 different cohort groups for the patients: 1) Unknown CRE colonisation status with increased barrier precautions (all patients until screening results arrive will belong to this group unless there are available screening results from referral hospital), 2) CREpos, and 3) CREneg. CREpos patients (2) will be treated in one area of the ICUs by specially assigned nurses/personnel.
  • Behavioral , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention
    The intervention will focus on two main measurable outcomes: 1) Decrease feco-oral-animal transmission route to prevent in-HH and community spread of CRE +/- CoRE. 2) Decrease unindicated community use of ABs for humans and animals. This WP focuses on a one health intervention in collaboration with local health authorities, developing and implementing an HH Education Communication Hygiene Intervention (HECHI) to improve HH hygiene and health management and reduce the risk of transmission between

Primary outcome measures

  • Change the prevalence of CRE colonisation [Time frame: 12 months from the starting of recruitment patients]
  • Cheng th prevalence of CRE transmission in the household [Time frame: 12 months from the starting of recruitment community participants]
  • Change the awareness regarding AMR of local people [Time frame: 18 months from the starting of recruitment community participants]
  • Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community [Time frame: 24 months from the starting of the project]
  • Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater [Time frame: 24 months from the starting of the project]

Eligibility criteria

Inclusion criteria

  • All patients under 2 years old at the selected hospital are highly appreciated to join the study.

Exclusion criteria

  • Patients not from the selected hospital and individuals outside the selected province

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

Vietnam · 1 center
  • Thai Binh Pediatric Hospital — Thái Bình

Identifiers

NCT: NCT05871476 · JPIAMR 2021-195

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗