Observational Study for SARS-Cov2 Epidemiological Surveillance on Healthcare Workers and Patients in a Rehabilitation Medicine Facility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of participants with positive RT-PCR against SARS-CoV2
研究概览
简要总结
The recent SARS-CoV2 pandemic has highlighted that the transmission of the virus within health care facilities plays a fundamental role in its propagation and, therefore, in the increase in COVID-19 cases registered among patients and healthcare workers.
This study, original for the current lack of data on nosocomial transmission mechanisms compared to what happens in the community, proposes to conduct a study in patients, health workers and people in real-life setting.
The study will be monocentric and performed at the San Raffaele Pisana Institute in Rome, that is able to guarantee the necessary number and the right case-mix that will allow to evaluate any possible correlations between infection and pre-existing disease.
详细描述
Furthermore, hospitals, especially those dedicated to chronic patients, as well as other communities that are not completely closed (such as school and work communities), are also at greater risk of small outbreaks that also affect healthcare professionals.
It is therefore necessary to carry out periodic checks on all healthcare professionals who work in healthcare facilities both to ensure their health and avoid the risk of possible contamination and to prevent the possible transmission of infection from the community to the hospital.
Another essential aspect to prevent infection in such facilities is the control of colonization in admitted patients.
Negativity from SARS-CoV2 should be carefully monitored in these patients prior to their placement in different departments.
On this basis, the study aims to determine the presence of SARS-CoV2 by monitoring with serial nasopharyngeal swabs carried out on healthcare professionals working within the facility and on new patients admitted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients/Participants > 18 years
- •Subjects who agree with the study signing the informed consent
排除标准
- •Age <18 years;
- •Pregnancy in progress;
- •Simultaneous participation in another clinical study
- •Ongoing immunosuppressive therapy or during the last month
结局指标
主要结局
Number of participants with positive RT-PCR against SARS-CoV2
时间窗: 15 days
All subjects will have 3 swabs done and analyzed
次要结局
- Number of participants with qualitative IgM/IgG positive results(15 days)