Prevalence and Associated Mortality of Infections by Multidrug-Resistant Organisms in Adults Intensive Care Units in Argentina (PREV-AR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,799
- 试验地点
- 7
- 主要终点
- prevalence of infection by MDRO
研究概览
简要总结
Observational 24-hr point prevalence study with longitudinal follow-up at 164 ICUs in Argentina. All adult patients (aged ≥18 years) at a participating ICU on November 24-28, 2023 with 60- day follow-up, were included. Epidemiological variables, sites of infection, isolated microorganisms, CPE colonisation, and hospital characteristics were collected. Main outcome measure was ICU mortality.
详细描述
Methods Study design PREVAR (PREValence of infection by MDR-microorganisms in ARgentina) was a national, cross-sectional, 24-hour multicentre study designed and conducted by SADI and SATI in Argentine ICUs.
Participants Sites were recruited to participate via announcements in national meetings, official societies' websites, social media, three online meetings explaining the project, and emails to all society members. Hospitals were registered on a secure website, where local investigators recorded main site characteristics in an electronic form.
Patient data were entered in an electronic case report form (CRF) using the Research Electronic Data Capture (REDCap) database (appendix 2). Local researchers were trained through online meetings on how to fill out the CRF. A centralized data center was responsible for managing the database and monitoring data quality in close contact with local researchers to minimize the occurrence of missing data. A dedicated email address was created to streamline communication.
Individual patient data were anonymised by assigning a numerical code to each case and recorded in order of admission.
Each local institutional review board approved the study and established the requirement for informed consent.
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
- 否
入选标准
- •All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included.
排除标准
- •There were no exclusion criteria.
结局指标
主要结局
prevalence of infection by MDRO
时间窗: All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.
The main outcome measure was the prevalence of infection by MDRO.
次要结局
- prevalence of colonisation by MDRO(All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.)
- prevalence of infection in general(All adult patients, 18 years and older, present on a participating ICU on the study day during the 24-h period (beginning at 8.00 a.m.) were included. The exact date could be selected from November 24-28, 2023.)
- ICU mortality(28 days)
研究者
MARIA INES STANELONI
MD
Hospital Italiano de Buenos Aires