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

NCT05871476 | Recruiting

• 1 other identifier: JPIAMR 2021-195
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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.

  12 months from the starting of recruitment patients

• 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.

  12 months from the starting of recruitment community participants

• 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.

  18 months from the starting of recruitment community participants

• 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.

  24 months from the starting of the project

• Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater

  The CRE isolated from rectal swab of patient admitted to hospital, household members, animals and wastewater will be subjected to Whole Genome Sequencing using Oxford MinION Nanopore/Illumina Miseq sequencing and bioinformatics analysis to investigate the mechanisms of resistance in different One-Health compartments.

  24 months from the starting of the project

Study Arms (2)

Intervention district

ACTIVE COMPARATOR

An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use.

Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention

cohort care at the hospital

ACTIVE COMPARATOR

A laminated note (yellow for "suspicious CRE carrier": green for (CRE-) patients and red for (CRE+) patients) should be put on the front of the patients' bed.

Behavioral: Hospital Cohort Care Intervention at the hospital

Interventions

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.

cohort care at the hospital

, 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.

Intervention district

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hanoi University of Public Health: lead
• 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

Study Sites (1)

Thai Binh Pediatric Hospital

Thái Bình, Thai Binh, 06122, Vietnam

RECRUITING

Study Officials

• Mattias Larsson, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Thirumalaisamy Velavan, PhD

  University of Tübingen, Germany

  PRINCIPAL INVESTIGATOR

• Håkan Hanberger

  Linkoeping University

  STUDY DIRECTOR

• Flavie Goutard, PhD

  CIRAD, France

  PRINCIPAL INVESTIGATOR

• Yaovi Mahuton Gildas Hounmanou, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Minh-Dien Tran

  Vietnam National Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Phuc Pham-Duc, MD, PhD

CONTACT

84904049969; pdp@huph.edu.vn

Viet-Linh Nguyen, BVetMed, PhD

CONTACT

vietlinh1603@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Center for Public Health and Ecosystem Research

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 23, 2023
• Study Start: July 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)