REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 42
- 主要终点
- Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
研究概览
简要总结
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Signed and dated informed consent form (ICF)
- •Age ≥ 18 years
- •Diagnosis of rCDI as determined by the treating physician
- •Completed antibiotic treatment for the presenting rCDI episode
- •Prescription for REBYOTA™ to prevent rCDI according to the approved indication
排除标准
- •Currently enrolled in an interventional clinical trial
研究组 & 干预措施
REBYOTA™
干预措施: REBYOTA™ (Drug)
结局指标
主要结局
Proportion of patients without Recurrence of Clostridioides Difficile Infection (rCDI) (as determined by the treating physician)
时间窗: 8 weeks after initial REBYOTA™ treatment
次要结局
- Hospitalizations and re-admissions during follow-up for up to 6 months (all-cause and CDI-related) after receiving REBYOTA™(Up to 6 months after receiving REBYOTA™)
- Total number of CDI episodes(6 months after initial REBYOTA™ treatment)
- Time to any CDI episode(6 months after initial REBYOTA™ treatment)
- Proportion of patients with sustained clinical response, defined as treatment success of the presenting rCDI episode and no new CDI episodes occurring for more than 8 weeks through 6 months after initial REBYOTA™ treatment(6 months after initial REBYOTA™ treatment)
- Daily mean changes in Clostridium difficile Infection-Daily Symptoms (CDIDaySyms™) scores from baseline to 7 days after REBYOTA™ administration(7 days after REBYOTA™ administration)