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

Официальное название

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

Обзор

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).

Вмешательства

• Поведенческое 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.
• Поведенческое , 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

Первичные конечные точки

• Change the prevalence of CRE colonisation [Срок оценки: 12 months from the starting of recruitment patients]
• Cheng th prevalence of CRE transmission in the household [Срок оценки: 12 months from the starting of recruitment community participants]
• Change the awareness regarding AMR of local people [Срок оценки: 18 months from the starting of recruitment community participants]
• Assessment the effectiveness of the hospital wastewater treatment on reducing CRE from hospital to community [Срок оценки: 24 months from the starting of the project]
• Investigate the genetic relatedness of CRE isolates from hospital, household, animals, wastewater [Срок оценки: 24 months from the starting of the project]

Критерии участия

Критерии включения

• All patients under 2 years old at the selected hospital are highly appreciated to join the study.

Критерии исключения

• Patients not from the selected hospital and individuals outside the selected province

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Вьетнам · 1 центр

• Thai Binh Pediatric Hospital — Thái Bình

Идентификаторы

NCT: NCT05871476 · JPIAMR 2021-195

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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