Incidence and Economic Burden of Community and Hospital- Acquired Clostridium Difficile Infections (CDI) in the German Health Care System (IBIS)
试验速览
- 阶段
- 不适用
- 入组人数
- 541
- 试验地点
- 6
- 主要终点
- Assessment of the cost of CDI index and recurrent episodes in German hospitals
研究概览
简要总结
IBIS is a prospective, observational study, which aims to assess the cost of CDI per day, hospitalization and year including description of incremental costs in hospitalized patients, and recurrent episodes, in German hospitals. Exposure to CDI drugs will not be influenced and remains at the discretion of the treating physician.
In addition to treatment, Health-related quality of life (HRQL) will be analyzed using standardized questionnaires.
详细描述
Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.
The following two differences of data documentation are observed:
- Retrospective data documentation:
Data of patients that are too sick to provide informed consent, (up to 30% of all patients enrolled) will be obtained retrospectively, at least 90 days after diagnosis and will be documented in an anonymized fashion. For these patients, documentation of HRQL will not be feasible. 2. Prospective data documentation:
Data of patients with an informed consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Index episode of CDI based on
- •the presence of diarrhea (defined as ≥3 unformed bowel movements/24h) plus
- •an enzyme immunoassay (EIA) detecting Glutamate dehydrogenase (GDH) or polymerase chain reaction (PCR) for toxin B test plus
- •a positive EIA for toxin A and B
- •Ongoing or new hospitalization at inclusion into the study.
- •Written informed consent (IC) has been obtained from the study subject or a legal representative.
排除标准
- •Patient with any social or logistical condition which in the opinion of the investigator may interfere with the conduct of the study, such as incapacity to well understand, not willing to collaborate, or cannot easily be contacted after discharge.
- •CDI episode within the previous 84 days.
结局指标
主要结局
Assessment of the cost of CDI index and recurrent episodes in German hospitals
时间窗: 90 days
Analyse direct and indirect costs associated with CDI per day, hospitalization and year including description of incremental costs in hospitalized patients.
次要结局
- Assessment of health-related quality of life (HRQL)(90 days)
研究者
Maria J.G.T. Vehreschild
PD MD
University of Cologne