Antimicrobial Stewardship Program Based on the Detection and Monitoring of Patients With Clostridium Difficile Infection (PACTA-ICD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Number of Participants With Clostridium Difficile Infection Recurrence.
研究概览
简要总结
The purpose of this study is to determine whether a bundle of measures specifically designed for patients with ICD and applied by and Infectious Diseases expert during a year period (2017) will improve the prognosis and reduce the rate of recurrence, compared with the baseline phase (2015) in which no intervention was made.
详细描述
Patients with CDI benefit from the assessment and monitoring by an Infectious Diseases (ID) expert. Early intervention in patients diagnosed with a first episode of CDI would reduce the unnecessary use of antibiotics, improve prognosis by ensuring compliance with the clinical practice guidelines and reduce the number of recurrences.
Primary objective:
• To improve the prognosis of patients with CDI hospitalized during the period of intervention:
- Increasing the compliance with clinical practice guidelines about specific treatment for CDI (for the episode that generated the intervention), depending on the severity of the episode and the existence of previous episodes
- Reducing the recurrence rate by means of a close follow-up during the period of higher risk, avoiding factors that are known to predispose to recurrence.
Secondary objectives:
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with CDI in the University Hospital "12 de Octubre", Madrid, Spain, requiring hospitalization or emergency room admission longer than 48 hours, from the beginning of the study on (estimated start date: January 2017).
- •Patient or his/her representative sign the inform consent
排除标准
- •Patients younger than 18 years of age.
- •Patients with the diagnosis of inflammatory bowel disease.
结局指标
主要结局
Number of Participants With Clostridium Difficile Infection Recurrence.
时间窗: Within 8 weeks after the end of treatment.
Number of patients with a Clostridium difficile infection recurrence in each group within the following 8 weeks after the end of specific treatment for the initial Clostridium difficile infection episode.
次要结局
- Number of Participants Experiencing More Than One Clostridium Difficile Infection Recurrence.(8 weeks after the end of specific treatment for the first recurrence of Clostridium difficile infection.)
- Number of Participants With The Right Choice Anti-Clostridium Difficile Infection Treatment (According to the Current Guidelines for Treatment of C. Difficile Infection).(In the following 48 hours to the positive diagnostic result.)
- Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Overuse.(In the following 48 hours to the positive diagnostic result.)
- Number of Participants With Antimicrobial Adjustment.(In the following 2 weeks to the positive diagnostic result.)
- All Cause Mortality(8 weeks after the positive diagnostic result.)
- Clostridium Difficile Infection Attributable Mortality Rate.(30 days after the positive diagnostic result.)
- Number of Participants With a Clostridium Difficile Infection That Received an Inappropriate Prescription by Underuse.(In the following 48 hours to the positive diagnostic result.)
研究者
José María Aguado García, MD, PhD
José María Aguado García, MD, PhD
Hospital Universitario 12 de Octubre