Interventions to Decrease CRE Colonization and Transmission Between Hospitals, Households, Communities and Domesticated Animals (I-CRECT)

Hanoi University of Public Health

Status: Enrolling

Conditions: Carbapenem-Resistant Enterobacteriaceae Infection; Antibiotic Resistant Infection

Treatments: Behavioral: Hospital Cohort Care Intervention at the hospital; Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05871476

JPIAMR 2021-195

Details and patient eligibility

About

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).

Enrollment: 800 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Intervention district

Active Comparator group

Description:

An information, communication, education and hygiene intervention, developed in collaboration with local health authorities, will aim to improve hygiene and decrease antibiotic use.

Treatment:

Behavioral: , Household Education Communication Hygiene Intervention, Livestock Antibiotic Intervention

cohort care at the hospital

Active Comparator group

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.

Treatment:

Behavioral: Hospital Cohort Care Intervention at the hospital