Diagnostic Performance and Acceptability of a Self-collected Rectal Swab for Screening of β Lactamase Extended Spectrum Enterobacterales
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Accuracy of the self-administered rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL Enterobacterales
研究概览
简要总结
The goal of this interventional study without drugs and medical devices is to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales
详细描述
This is an experimental study without drugs and medical devices to assess the accuracy of the self-administered rectal swab compared to the "gold standard" performed by healthcare professionals used for the diagnosis of βlactamase extended spectrum (ESBL) Enterobacterales in patients admitted to the hospital without a scheduled intestinal surgery.
Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver will be compared th screening rectal swab performed by the nurse. Swabs will be stored in the ward refrigerator until delivery to the Microbiology laboratory within 24 hours from collection, where they will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for patient:
- •18 years of age and above
- •Suitability of swab collection within 48 hours from hospitalization
- •Signed informed consent and authorization for the participation in the study and for the use of personal data
- •Inclusion Criteria for caregiver:
- •Age over 18 years
- •Patient's consent to have the rectal swab performed by their caregiver
- •Caregiver signed informed consent
- •Availability to perform the rectal swab on the patient
排除标准
- •for patient:
- •Hospitalization in the previous 90 days for at least 2 days (excluding Day Hospital)
- •Hospitalization in the previous 90 days of ≥2 days in nursing homes or community hospitals
- •Patients in emergency situations
研究组 & 干预措施
Rectal swab performed by the patient (or the caregiver) and then by the nurse
Rectal swab (Smart eNAT) collection procedure performed by the patient (or the caregiver) and then by the nurse. Both samples will be analyzed within 24 hours from collection
干预措施: Rectal swab collection procedure performed by the patient (or the caregiver) and then by the nurse (Diagnostic Test)
结局指标
主要结局
Accuracy of the self-administered rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL Enterobacterales
时间窗: 24 hours after swabs collection
次要结局
- Prevalence of ESBL-E in the community population prior to hospital admission(24 hours after swabs collection)
- Accuracy of the caregiver rectal swab compared to the swab performed by healthcare professionals (nurses) used for the diagnosis of ESBL- Enterobacterales(24 hours after swabs collection)
- Study questionnaire results on acceptability of patients self-administering rectal swabs(through hospital discharge, an avarage of 1 week)