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

NCT ID: NCT05871476

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Antibiotic Resistant Infection Carbapenem-Resistant Enterobacteriaceae Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention district

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

Group Type ACTIVE_COMPARATOR

, Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention

Intervention Type 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.

cohort care at the hospital

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.

Group Type ACTIVE_COMPARATOR

Hospital Cohort Care Intervention at the hospital

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Universität Tübingen

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

National Children's Hospital, Vietnam

OTHER

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

International Centre for Antimicrobial Resistance Solutions

UNKNOWN

Sponsor Role collaborator

Hanoi University of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Pham-Duc Phuc

Deputy Director of Center for Public Health and Ecosystem Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mattias Larsson, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Thirumalaisamy Velavan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tübingen, Germany

Håkan Hanberger

Role: STUDY_DIRECTOR

Linkoeping University

Flavie Goutard, PhD

Role: PRINCIPAL_INVESTIGATOR

CIRAD, France

Yaovi Mahuton Gildas Hounmanou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Minh-Dien Tran

Role: PRINCIPAL_INVESTIGATOR

Vietnam National Children's Hospital

Locations

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Thai Binh Pediatric Hospital

Thái Bình, Thai Binh, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Phuc Pham-Duc, MD, PhD

Role: CONTACT

84904049969

Viet-Linh Nguyen, BVetMed, PhD

Role: CONTACT

Facility Contacts

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Thi Nhu Pham, MD

Role: primary

0986155211

Other Identifiers

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JPIAMR 2021-195

Identifier Type: -

Identifier Source: org_study_id

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