The Extended Study of Prevalence of Infection in Intensive Care IV (EPIC IV)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- All-cause mortality at hospital discharge
研究概览
简要总结
The goal of this observational study is to learn how common infections are in intensive care units (ICUs) around the world and how they are treated. The study will look at all adults in the ICU during a single 24-hour period. The main questions it aims to answer are:
- What types of infections and antibiotic-resistant bacteria are most common in ICUs worldwide?
- How do resistance patterns affect how participants are treated and how they recover?
How are antibiotics used in ICUs, and how do hospitals practice antibiotic stewardship?
- What organ support treatments do participants with infections receive?
- What are the outcomes of participants with severe infections, including survival at hospital discharge (up to 60 days)?
Researchers will compare ICUs across regions and income levels to see how infection patterns, treatments, and outcomes differ around the world.
Participants will:
- Be counted if they are present in the ICU at any time during the study day.
- Have information collected from their medical record about their health, the infection they may have, treatments they receive, and their outcome at ICU and hospital discharge (up to 60 days).
Because this is an observational study, participants will not receive any new treatments as part of the study.
详细描述
The Extended Prevalence of Infection in Intensive Care IV (EPIC IV) study is an international, multicenter, prospective 24-hour point-prevalence study designed to provide an updated global assessment of infection patterns, antimicrobial use, organ support strategies, and related outcomes among adult patients treated in intensive care units (ICUs).
This study follows the methodology of previous EPIC initiatives (1998, 2007, 2017), while addressing the substantial changes in infection epidemiology observed in the post-COVID-19 era, including shifts in microbial resistance profiles and ICU practice patterns. Each participating ICU will select a single study day within the predefined window, during which all patients aged ≥18 years who are present in the unit at any time during the 24-hour period will be included.
Data collection will be standardized across sites and will include:
- Patient-level information on demographics, comorbidities, admission characteristics, severity-of-illness scores (APACHE II, SAPS II, SOFA), organ dysfunction, microbiology results, antimicrobial therapies, and supportive treatments.
- Unit-level characteristics related to ICU organization, staffing, resource availability, and antimicrobial stewardship practices.
- Follow-up data on ICU and hospital outcomes, censored at 60 days after the study day.
No study-specific treatments or interventions will be administered. All clinical care will follow local practice. Microbiological testing and therapeutic decisions will not be influenced by the study protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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) treated in the participating ICUs on the study day.
排除标准
- •Patients under 18 years
研究组 & 干预措施
All patients present on or admitted to a contributing ICU on the study day
None interventions
结局指标
主要结局
All-cause mortality at hospital discharge
时间窗: Up to 60 days after the study day
The primary outcome measure is all-cause mortality at hospital discharge, censored at 60 days from the study day. Mortality status will be assessed at ICU discharge and again at hospital discharge or Day 60, whichever occurs first.
次要结局
- ICU mortality(From ICU admission to ICU discharge (up to 60 days))
- ICU and hospital lengths of stay(From ICU/hospital admission to discharge (up to 60 days))
- Organ Failure(From ICU/hospital admission to discharge (up to 60 days))
- Antimicrobial Resistance(From ICU/hospital admission to discharge (up to 60 days))