Antibiotic Resistant InfectionI-CRECTNCT05871476
Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
A study testing Hospital Cohort Care Intervention at the hospital and , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention in people with Antibiotic Resistant Infection and Carbapenem-Resistant Enterobacteriaceae Infection, run by Hanoi University of Public Health at 1 site in Vietnam.
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… Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Resistant Infection, Carbapenem-Resistant Enterobacteriaceae Infection
- What is being tested?
- Hospital Cohort Care Intervention at the hospital and , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients under 2 years old at the selected hospital are highly appreciated to join the study.
Who cannot join
- Patients not from the selected hospital and individuals outside the selected province
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Viet-Linh Nguyen, BVetMed, PhD contact
Vietnam1 site, 1 recruiting
- Recruiting
Thai Binh Pediatric Hospital
Thái Bình, Thai Binh, 06122
Thi Nhu Pham, MD, 0986155211
About this study
Official title: Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
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).
- Being tested
- Hospital Cohort Care Intervention at the hospital, , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Cohort Care Intervention at the hospitalBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention district | Active comparator | An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use. Receives: Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention |
| cohort care at the hospital | Active comparator | 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. Receives: Behavioral: Hospital Cohort Care Intervention at the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from the starting of recruitment patients
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.
Measured: 12 months from the starting of recruitment community participants
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.
Measured: 18 months from the starting of recruitment community participants
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.
Measured: 24 months from the starting of the project
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.
Measured: 24 months from the starting of the project
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi University of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping 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
- Responsible party
- Principal investigator, Pham-Duc Phuc, Hanoi University of Public Health
- Investigators
- Mattias Larsson, MD, Principal investigator, Karolinska InstitutetThirumalaisamy Velavan, PhD, Principal investigator, University of Tübingen, GermanyHåkan Hanberger, Study director, Linkoeping UniversityFlavie Goutard, PhD, Principal investigator, CIRAD, FranceYaovi Mahuton Gildas Hounmanou, PhD, Principal investigator, University of CopenhagenMinh-Dien Tran, Principal investigator, National Children's Hospital, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871476
- Sponsor's protocol ID
- JPIAMR 2021-195
- Acronym
- I-CRECT
- Status last verified
- Jun 2025
- First submitted
- 4 May 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
- ClinicalTrials.gov ID
- NCT05871476
- Acronym / sponsor ID
- I-CRECT / JPIAMR 2021-195
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hanoi University of Public HealthUniversity, hospital or other
- Collaborators
- Linkoeping 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
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention district | Active comparator | Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic InterventionAn 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 | Active comparator | Behavioral: Hospital Cohort Care Intervention at the hospitalA 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients under 2 years old at the selected hospital are highly appreciated to join the study.
Key exclusion criteria (1 listed)
- Patients not from the selected hospital and individuals outside the selected province
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital Cohort Care Intervention at the hospitalThere 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. | Behavioural | cohort care at the hospital |
| , Household Education Communication Hygiene Intervention, Livestock Antibiotic InterventionThe 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. | Behavioural | Intervention district |
Primary outcome
Change the prevalence of CRE colonisation
Time frame: 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.
Cheng th prevalence of CRE transmission in the household
Time frame: 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.
Change the awareness regarding AMR of local people
Time frame: 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.
Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community
Time frame: 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.
Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Viet-Linh Nguyen, BVetMed, PhD contact
Mattias Larsson, MD principal investigator
Karolinska Institutet
Thirumalaisamy Velavan, PhD principal investigator
University of Tübingen, Germany
Håkan Hanberger study director
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital Cohort Care Intervention at the hospital and , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention in people with Antibiotic Resistant Infection and Carbapenem-Resistant Enterobacteriaceae Infection, run by Hanoi University of Public Health at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phuc Pham-Duc, MD, PhD (84904049969, pdp@huph.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change the prevalence of CRE colonisation (time frame: 12 months from the starting of recruitment patients). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.