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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorHanoi University of Public Health

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hospital Cohort Care Intervention at the hospital

    Behavioral

    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.

  • , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention

    Behavioral

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Intervention districtActive comparator 1 intervention
Group B: cohort care at the hospitalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change the prevalence of CRE colonisation

The intervention at hospital will lead to the reduction of CRE colonisation, hospital acquire infection, treatment duration and costs.

Time frame
12 months from the starting of recruitment patients
2

Cheng th prevalence of CRE transmission in the household

The Household Education Communication Hygiene Intervention expected to reduce the transmission of CRE from index patient to household member.

Time frame
12 months from the starting of recruitment community participants
3

Change the awareness regarding AMR of local people

The understanding on AMR, particularly of CRE, proper use of antibiotic for both humans and animals, will be improved. This will be measured through the quantitative questionnaires.

Time frame
18 months from the starting of recruitment community participants
4

Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community

The presence of CRE in hospital wastewater before and after treatment will be compared to evaluate the effectiveness of the treatment system on preventing the spreading of AMR to the community.

Time frame
24 months from the starting of the project

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanoi University of Public Health

Lead sponsor

Linkoeping University

Collaborator

Karolinska Institutet

Collaborator

Universität Tübingen

Collaborator

University of Copenhagen

Collaborator

National Children's Hospital, Vietnam

Collaborator

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

Collaborator

International Centre for Antimicrobial Resistance Solutions

Collaborator