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

Not Applicable

Recruiting

• Conditions: Antibiotic Resistant Infection; Carbapenem-Resistant Enterobacteriaceae Infection
• Interventions: Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention; Behavioral: Hospital Cohort Care Intervention at the hospital

• Registration Number: NCT05871476
• Lead Sponsor: Hanoi University of Public Health

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2025-03-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention district	, Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention	An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use.
cohort care at the hospital	Hospital Cohort Care Intervention 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.

Primary Outcome Measures

Name	Time	Method
Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater	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.
Cheng th prevalence of CRE transmission in the household	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.
Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community	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.
Change the prevalence of CRE colonisation	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.
Change the awareness regarding AMR of local people	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.

Trial Locations

Locations (1)

Thai Binh Pediatric Hospital; 🇻🇳 Thái Bình, Thai Binh, Vietnam