Incidence, Clinical Characteristics, Strain Characterization, Treatment and Outcome of Clostridium Difficile Infection (CDI) in Hematologic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Incidence
研究概览
简要总结
The microbiology department prospectively generates a data base of all episodes of Clostridium difficile infection (CDI) in the institution, the investigators will analyse the evolution of the episodes and the incidence per 10,000 days of stay of cases of diagnosed CDI in the Hematological wards and the rest of the hospital during the 2006-2018 period. The investigators will also compare the impact on haematological paediatric population.
In order to analyse the clinical and epidemiological characteristics of CDI in this population, a case and control study will be conducted, reviewing the medical records of patients who have had an episode of diarrhoea caused by C. difficile in an hematological unit, which will be compared with non-hematological patients who have had an CDI episode These patients will be selected randomly from the Microbiology Department database. The sample size will be 400 patients, 200 per arm. The histories will be reviewed according to a pre-established clinical protocol including epidemiological, clinical, therapeutic and evolution variables.
A prospective study in 2019-2020 will also be conducted. The investigators will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively.
详细描述
A retrospective case control study (2006-2018) and a prospective study 2019-2020.
Study subjects
All patients diagnosed with a hematological disease who had a detection of toxigenic Clostridium difficile in the laboratory within the 2006-2018 period will be included in the study. Hematological patients with a negative Clostridium difficile infection (CDI) test in the same period will be included as controls, For controls, out of the number of cases within that study period, 200 will be randomly selected with the aid of the Excel software, with the tools randomization (RAND) and INDEX to ensure there is no bias. For each patient a protocol data will be filled retrospectively including the variables listed below.
Additionally, a prospective study in 2019-2020 will also be conducted. We will include all patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile. Patients will be followed for at least 2 months. For each patient a protocol data will be filled prospectively including the variables listed below.
For all the study period 2006-2018 a total of approximately 200 patients will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with a hematological disease who had a detection of toxigenic Clostridium difficile in the laboratory within the 2006-2018 period will be included in the study. Hematological patients with a negative CDI test in the same period will be included as controls.
- •All patients diagnosed with an hematological/oncological disease or with any immunosuppressive condition, who have a positive detection of toxigenic Clostridium difficile in 2019.
排除标准
- 未提供
结局指标
主要结局
Incidence
时间窗: 2006-2020
number of CDI cases/ 10,000 patient days
次要结局
- Recurrence of CDI(2006-2020)
- Mortality attributable to CDI(2006-2020)
研究者
Emilio Bouza
Clinical Professor
Hospital General Universitario Gregorio Marañon