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NCT Number: NCT05871476

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

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).

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Key information

Conditions

Antibiotic Resistant Infection Carbapenem-Resistant Enterobacteriaceae Infection

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thai Binh Pediatric Hospital

Thái Bình, Thai Binh, 06122, Vietnam

Location status: Recruiting

Location contact

Thi Nhu Pham, MD

CONTACT

0986155211

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change the prevalence of CRE colonisation

    Time frame: 12 months from the starting of recruitment patients

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

  2. Cheng th prevalence of CRE transmission in the household

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

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

  3. Change the awareness regarding AMR of local people

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

    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.

  4. 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

    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.

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

    Time frame: 24 months from the starting of the project

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Phuc Pham-Duc, MD, PhD

CONTACT

[email protected]

84904049969

Viet-Linh Nguyen, BVetMed, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hanoi University of Public Health

Other

Collaborators

  • Centre de coopération internationale en recherche agronomique pour le développement (CIRAD)
  • International Centre for Antimicrobial Resistance Solutions
  • Karolinska Institutet
  • Linkoeping University
  • National Children's Hospital, Vietnam
  • University of Copenhagen
  • Universität Tübingen

Registry information

Official study title

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

Acronym: I-CRECT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 23, 2023
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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