Clinical trial NCT05871476: Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
Official title: Interventions to Decrease Carbapenem Resistant Enterobacteriaceae Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Antibiotic Resistant Infection
Carbapenem-Resistant Enterobacteriaceae Infection
Lead sponsor: Hanoi University of Public Health
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Karolinska Institutet
name: Universität Tübingen
name: University of Copenhagen
name: National Children's Hospital, Vietnam
name: Centre de coopération internationale en recherche agronomique pour le développement (CIRAD)
name: International Centre for Antimicrobial Resistance Solutions
First posted: 2023-05-23
Enrollment: 800
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).


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

Primary outcomes:
measure: Change the prevalence of CRE colonisation
timeFrame: 12 months from the starting of recruitment patients
measure: Cheng th prevalence of CRE transmission in the household
timeFrame: 12 months from the starting of recruitment community participants
measure: Change the awareness regarding AMR of local people
timeFrame: 18 months from the starting of recruitment community participants
measure: Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community
timeFrame: 24 months from the starting of the project
measure: Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater
timeFrame: 24 months from the starting of the project
Secondary outcomes:
Other outcomes:
Locations:
city: Thái Bình
country: Vietnam
facility: Thai Binh Pediatric Hospital
state: Thai Binh
Study officials:
affiliation: Karolinska Institutet
name: Mattias Larsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tübingen, Germany
name: Thirumalaisamy Velavan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Håkan Hanberger
role: STUDY_DIRECTOR
affiliation: CIRAD, France
name: Flavie Goutard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Yaovi Mahuton Gildas Hounmanou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vietnam National Children's Hospital
name: Minh-Dien Tran
role: PRINCIPAL_INVESTIGATOR
References: