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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05871476
Acronym
I-CRECT
Enrollment
800
Registered
2023-05-23
Start date
2022-07-01
Completion date
2026-06-30
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection, Carbapenem-Resistant Enterobacteriaceae Infection

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).

Interventions

BEHAVIORALHospital 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

Linkoeping University
CollaboratorOTHER_GOV
Karolinska Institutet
CollaboratorOTHER
Universität Tübingen
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
National Children's Hospital, Vietnam
CollaboratorOTHER
Centre de coopération internationale en recherche agronomique pour le développement (CIRAD)
CollaboratorUNKNOWN
International Centre for Antimicrobial Resistance Solutions
CollaboratorUNKNOWN
Hanoi University of Public Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change the prevalence of CRE colonisation12 months from the starting of recruitment patientsThe intervention at hospital will lead to the reduction of CRE colonisation, hospital acquire infection, treatment duration and costs.
Cheng th prevalence of CRE transmission in the household12 months from the starting of recruitment community participantsThe Household Education Communication Hygiene Intervention expected to reduce the transmission of CRE from index patient to household member.
Change the awareness regarding AMR of local people18 months from the starting of recruitment community participantsThe 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.
Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community24 months from the starting of the projectThe 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.
Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater24 months from the starting of the projectThe 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.

Countries

Vietnam

Contacts

Primary ContactPhuc Pham-Duc, MD, PhD
pdp@huph.edu.vn84904049969
Backup ContactViet-Linh Nguyen, BVetMed, PhD
vietlinh1603@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026