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

Summary

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).

Conditions

• Antibiotic Resistant Infection
• Carbapenem-Resistant Enterobacteriaceae Infection

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 humans and animals, a Provider Engagement Intervention (PEI) to improve case management of common infection and decrease unindicated AB, and and a Livestock AB Intervention (LAI) to reduce the use of AB in livestock through improved biosecurity conditions and animal husbandry.

Sponsors & Collaborators

• Linkoeping University

  collaborator OTHER_GOV

• Karolinska Institutet

  collaborator OTHER

• Universität Tübingen

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• National Children's Hospital, Vietnam

  collaborator OTHER

• Centre de coopération internationale en recherche agronomique pour le développement (CIRAD)

  collaborator UNKNOWN

• International Centre for Antimicrobial Resistance Solutions

  collaborator UNKNOWN

• Hanoi University of Public Health

  lead OTHER

Principal Investigators

• Mattias Larsson, MD · Karolinska Institutet

• Thirumalaisamy Velavan, PhD · University of Tübingen, Germany

• Håkan Hanberger · Linkoeping University

• Flavie Goutard, PhD · CIRAD, France

• Yaovi Mahuton Gildas Hounmanou, PhD · University of Copenhagen

• Minh-Dien Tran · Vietnam National Children's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

24 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2025-12-31

Completion

2026-06-30

Countries

• Vietnam

Study Locations