An International Observational Study of Adults With Acute Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 69
- 主要终点
- Day 28 Mortality
研究概览
简要总结
Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
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
- •Age ≥18 years old
- •Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.
- •Onset of symptoms of an infectious disease within the past 30 days.
- •Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.
排除标准
- •Current imprisonment (this does not include quarantine for an infectious disease).
- •Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.
- •Expected inability or unwillingness to participate in study procedures.
- •In the opinion of the investigator, participation in the study is not in the best interest of the patient.
研究组 & 干预措施
Study group
The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection.
干预措施: No intervention (Other)
结局指标
主要结局
Day 28 Mortality
时间窗: Day 28
All-cause mortality
Days to recovery scale (DRS)
时间窗: Day 28
The Days to Recovery Scale (DRS) is an ordinal ranked outcome that includes the concepts of mortality and time to recovery, with recovery defined as being discharged from the hospital and reaching home for the duration of the follow- up. At the end of the follow-up period, each patient is classified into one of the DRS categories based on vital status, hospitalization status, and duration it took to reach recovery.
Time to Sustained Recovery
时间窗: Day 28
Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.
Ordinal outcome for clinical improvement - Day 7
时间窗: Day 7
For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.
Organ support free days
时间窗: Day 28
the number of days between enrollment and hospital discharge or day 28 that the participant did not receive support for some organ (lungs, kidneys, etc.)
The Sequential Organ Failure Assessment (SOFA) score - Day 28
时间窗: Day 28
The SOFA score is one of the most widely used scoring systems in critically ill patients and has also been validated in hospitalized patients with suspected infection outside the ICU. This score assesses organ dysfunction across 6 organ systems. To facilitate use of the SOFA score across a broad range of sites, including those in low- and-middle income countries (LMICs), SpO2 may be substituted for PaO2, and the presence of scleral icterus or jaundice may be substituted for serum bilirubin level . Only clinically available data will be used to calculate SOFA scores. Laboratory tests will not be completed by the study to calculate SOFA scores.
次要结局
未报告次要终点