Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence. BEFORE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 869
- 试验地点
- 6
- 主要终点
- Hospital stays
研究概览
简要总结
The main hypothesis of the study is that Bezlotoxumab is well tolerated and effective in reducing the recurrence of ICD (Clostridium Difficile infection) in patients with a high risk of recurrence in the first episode of ICD.
As a consequence, the number of readmissions and hospital stays, will be reduced in patients treated with Bezlotoxumab.
详细描述
This is a comparative study of patients with a high risk of recurrence of ICD in the first episode, treated with Bezlotoxumab (together with standard ICD therapy), with patients with first episode of ICD from a paired retrospective cohort (1: 2) using a propensity score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 who have granted the IC and who are going to comply with the study visits and procedures according to their life expectations.
- •Patient ≥ 18 years of age
- •Having a first episode of DCI and presenting an estimated recurrence risk greater than 35%.
排除标准
- •Patients <18 years old
- •Pregnant or lactating women
- •Women of childbearing age who are not willing to use an appropriate contraceptive method (such as oral contraceptives, intrauterine device or contraceptive barrier method along with spermicide or surgical sterilization) during the study.
- •Life expectancy less than 6 months
- •Impossibility or serious difficulties of clinical follow-up
- •Any digestive disease that, at the discretion of the researcher, makes it difficult to assess the response due to impaired bowel habits.
- •Immunoglobulin treatment in the last 3 months
- •Previous treatment with Bezlotoxumab
- •Treatment with an experimental drug in the previous 30 days or participating or planning to participate in any other clinical trial with an experimental drug during the 12-week trial period.
- •Anti- ICD treatment forecast for more than 14 days (eg vancomycin in descending pattern) for the current episode.
- •Health center staff
- •Direct family members of the research team
研究组 & 干预措施
Prospective cohort
64 patients treated with Bezlotoxumab
干预措施: Bezlotoxumab Injection [Zinplava] (Drug)
结局指标
主要结局
Hospital stays
时间窗: Throughout the study until 24 weeks after the diagnosis of ICD
Total days of hospitalization of patients
Recurrence rate
时间窗: Week 24
% of patients who, having presented cure of the episode of ICD, develop recurrence of ICD after the treatment of the first episode.
Rate of healing of the ICD episode defined as absence of diarrhea within 48 hours after the end of the episode treatment.
时间窗: 48 hours after the end of the episode treatment
Percentage of readmissions due to ICD
时间窗: From the 'Treatment visit' up to week 24 post -treatment visit ( an average of 24 weeks)
Adverse events related with the infusion
时间窗: 2 hours (1 hour during the infusion and 1 hour post infusion)
Rate of adverse events. Sampson criteria will be used to define anaphylaxis will be used
Rate of cardiological safety events.
时间窗: Throughout the study completion, an average of 26 weeks
Episodes of acute coronary síndrome, arrhythmia, heart failure Will be recorded
次要结局
未报告次要终点