NCT03574532已完成不适用
A Retrospective Non-Interventional Study to Determine the Epidemiology and Evaluate the Burden of Disease in Respiratory Syncytial Virus/Human Metapneumovirus and Influenza A Infected Hospitalized Patients (Adults and Children) at Selected European Sites
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Burden as Measured by Medical Resource Utilization, Complications, Mortality, Re-hospitalizations and Post Discharge Care Information
研究概览
简要总结
The purpose of this study is to describe the clinical and economic burden in adults and infants/children less than or equal to 5 years of age by type of respiratory pathogen (respiratory syncytial virus [RSV], influenza A, and human metapneumovirus [hMPV] in adults; RSV and hMPV in infants/children) based on medical resource utilization; rate and type of complications during and after hospitalization; mortality; rate and reasons of re-hospitalization related to index hospitalization; post-discharge care information and International Classification of Diseases 9th/10th revision (ICD-9/10)/Diagnostic-related Group (DRG) codes used (distribution).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult greater than or equal to (>=) 18 years of age or infant/child less than or equal to (=<) 5 years of age
- •Participants hospitalized must have documentation of a confirmed diagnosis by PCR during the prespecified recent past season(s): RSV, influenza A, or hMPV infection in adults RSV or hMPV in infants/children (The first hospitalization in the season of data collection with confirmed diagnosis by PCR is considered the index hospitalization)
- •Participants may include those hospitalized in the season of data collection with or without symptoms of a respiratory viral infection (including those of nosocomial origin), and/or to treat complications of viral infections, including patients admitted to the intensive care unit (ICU)
- •Hospitalized greater than (>) 24 hours
排除标准
- 未提供
结局指标
主要结局
Burden as Measured by Medical Resource Utilization, Complications, Mortality, Re-hospitalizations and Post Discharge Care Information
时间窗: Up to 6 months after discharge
Number of participants with medical resource utilization, complications, mortality, re-hospitalizations and post discharge care information will be assessed.
次要结局
- Number of Participants Without Presenting Symptoms of Acute Respiratory Tract Infection (ARTI)(During hospitalization (up to maximum 12 months))
- Participant's Clinical Status Assessed by Hospital Recovery Scale (HRS)(Baseline, Day 4, Day 6 and Day 14)
- ReSVinet score used at Time of Admission to the Hospital in Infants/Children, and Relevance on MRU by Type of Respiratory Pathogen(At Admission (Day 1))
- Number of Participants in Various Subgroups of Hospitalized Patients by Type of Respiratory Pathogen(During hospitalization (up to maximum 12 months))
- CRB-65 Scoring System at Admission to the Hospital for Adults with Lung Disease and the Relevance on Medical Resource Utilization (MRU) by type of Respiratory Pathogen(At admission (Day 1))
- Simplified Acute Physiology Scores 3 (SAPS 3) in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen(At ICU admission (up to maximum 12 months))
- Medical Resources Utilization by Estimated Glomerular Filtration Rate (eGFR)(Baseline)
- Levels of Neutrophils During Hospitalization(During hospitalization (up to maximum 12 months))
- Number of Participants (infants/children) with RSV and hMPV Infection(During hospitalization (up to maximum 12 months))
- Patient Journey(During hospitalization and up to 6 months after discharge)
- Change of National Early Warning Score (NEWS) for Adults at Admission, Day 3, and Day 6(At admission (Day 1), Day 3, and Day 6)
- Levels of C-Reactive Protein During Hospitalization(During hospitalization (up to maximum 12 months))
- Symptoms of Participants Presenting at Hospital(At admission (Day 1) and at discharge)
- Medical Resources Utilization by Type of Virus Infection(Baseline)
- Levels of White Blood cell During Hospitalization(During hospitalization (up to maximum 12 months))
- Number of Participants (Adults) with RSV, Influenza A and hMPV Infections(During hospitalization (up to maximum 12 months))
- Number of Participants with Respiratory Infections of Nosocomial Origin With or Without Presenting Symptoms(During hospitalization (up to maximum 12 months))
- Criteria Applied for the Index-Hospitalization, Transfer to ICU, Discharge From Hospital(At admission, at ICU admission, at discharge (up to maximum 12 months))
- Acute Physiologic and Chronic Health Evaluation (APACHE II) Scores in Adults at ICU Admission and the Relevance on MRU by Type of Respiratory Pathogen(At ICU admission (up to maximum 12 months))
- Levels of Procalcitonin During Hospitalization(During hospitalization (up to maximum 12 months))
- Levels of Viral Load During Hospitalization(During hospitalization (up to maximum 12 months))
研究者
研究点 (2)
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