Observational Study to Assess Clinical Management Patterns in Patients With Hospitalised Community-Acquired Pneumonia (CAP) or Complicated Skin and Skin Structure Infections (cSSSI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,035
- 试验地点
- 1
- 主要终点
- Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness
研究概览
简要总结
This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- •Patients hospitalised with CAP or cSSSI
- •CAP: Radiographically-confirmed bacterial pneumonia AND Requiring treatment with IV antimicrobials as start-up therapy
- •cSSSI: Affecting deeper soft tissue and/or requiring significant surgical intervention or developing an abcess/ulcer/cellulitis in a lower limb AND Having at least two local signs and one systemic sign of cSSS AND Treatment with antimicrobials
排除标准
- •Patients already participating in clinical trials or any other interventional study.
- •CAP: CAP suitable for outpatient therapy with an oral antimicrobial agent.
- •cSSSI: Uncomplicated SSSI. Skin and skin-structure infections with a high cure rate after surgical incision alone or after aggressive local skin care.
结局指标
主要结局
Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness
时间窗: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).
Number of patients reaching clinical stability, as a measure of effectiveness
时间窗: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).
Number of patients death, as a measure of clinical failure
时间窗: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).
Number of patients with infection recurrence, as a measure of clinical failure
时间窗: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).
Number of patients requiring change in antibiotic, as a measure of clinical failure
时间窗: Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).
次要结局
- Number of patients hospitalized with CAP or cSSSI, in each type of hospital and department, as a descriptive measure of burden of disease, and patient flow.(Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31.)
- Number and type of diagnostic tests, as measure of use of resources(Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)
- Type of medications used, as measure of use of resources(Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)
- Duration of hospitalisation, as measure of use of resources(Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)
- Number of patients requiring ICU / isolation / mechanical ventilation / complications, as measure of use of resources(Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)
- No. patients infected with MR-Staphylococcus aureus in cSSSI, or with PR-Streptococcus pneumoniae in CAP, not responding to antibiotic treatment, as measure of prevalence of resistant strains and of incidence of associated clinical failure(Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)