Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals (I-CRECT)
Primary Purpose
Antibiotic Resistant Infection, Carbapenem-Resistant Enterobacteriaceae Infection
Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Hospital Cohort Care Intervention at the hospital
, Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention
Sponsored by
About this trial
This is an interventional screening trial for Antibiotic Resistant Infection
Eligibility Criteria
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
Sites / Locations
- Thai Binh Pediatric HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention district
cohort care at the hospital
Arm Description
An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05871476
First Posted
May 4, 2023
Last Updated
May 23, 2023
Sponsor
Hanoi University of Public Health
Collaborators
Linkoping University, Karolinska Institutet, Universität Tübingen, University of Copenhagen, National Children's Hospital, Vietnam, Centre de coopération internationale en recherche agronomique pour le développement (CIRAD), International Centre for Antimicrobial Resistance Solutions
1. Study Identification
Unique Protocol Identification Number
NCT05871476
Brief Title
Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
Acronym
I-CRECT
Official Title
Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanoi University of Public Health
Collaborators
Linkoping University, Karolinska Institutet, Universität Tübingen, University of Copenhagen, National Children's Hospital, Vietnam, Centre de coopération internationale en recherche agronomique pour le développement (CIRAD), International Centre for Antimicrobial Resistance Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Resistant Infection, Carbapenem-Resistant Enterobacteriaceae Infection
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention district
Arm Type
Active Comparator
Arm Description
An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use.
Arm Title
cohort care at the hospital
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hospital Cohort Care Intervention at the hospital
Intervention Description
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
Intervention Name(s)
, Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change the prevalence of CRE colonisation
Description
The intervention at hospital will lead to the reduction of CRE colonisation, hospital acquire infection, treatment duration and costs.
Time Frame
12 months from the starting of recruitment patients
Title
Cheng th prevalence of CRE transmission in the household
Description
The Household Education Communication Hygiene Intervention expected to reduce the transmission of CRE from index patient to household member.
Time Frame
12 months from the starting of recruitment community participants
Title
Change the awareness regarding AMR of local people
Description
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.
Time Frame
18 months from the starting of recruitment community participants
Title
Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community
Description
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.
Time Frame
24 months from the starting of the project
Title
Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater
Description
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.
Time Frame
24 months from the starting of the project
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phuc Pham-Duc, MD, PhD
Phone
+84 904049969
Email
pdp@huph.edu.vn
First Name & Middle Initial & Last Name or Official Title & Degree
Viet-Linh Nguyen, BVetMed, PhD
Email
vietlinh1603@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Larsson, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thirumalaisamy Velavan, PhD
Organizational Affiliation
University of Tübingen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Håkan Hanberger
Organizational Affiliation
Linköping University, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Flavie Goutard, PhD
Organizational Affiliation
CIRAD, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaovi Mahuton Gildas Hounmanou, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Minh-Dien Tran
Organizational Affiliation
Vietnam National Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thai Binh Pediatric Hospital
City
Thái Bình
State/Province
Thai Binh
ZIP/Postal Code
06122
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thi Nhu Pham, MD
Phone
0986155211
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
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