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

Antibiotic Resistant Infection Clinical Trial

— I-CRECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871476
• Other study ID #: JPIAMR 2021-195
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2023
• Source: Hanoi University of Public Health
• Contact: Phuc Pham-Duc, MD, PhD
• Phone: +84 904049969
• Email: pdp[@]huph.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Carbapenem-Resistant Enterobacteriaceae Infection
• Communicable Diseases
• Enterobacteriaceae Infections
• Infections

Intervention

Behavioral:
• 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.
• , 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.

Locations

Country	Name	City	State
Vietnam	Thai Binh Pediatric Hospital	Thái Bình	Thai Binh

Sponsors (8)

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

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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