The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,986
- 试验地点
- 6
- 主要终点
- Number of patients with a composite outcome of bacteremia or death by 6 months.
研究概览
简要总结
The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI). The study tests whether cephalosporin plus beta-lactam antibiotic with spectrum for Enterococcus faecalis as per procedural prophylaxis is superior to cephalosporin alone in reducing the composite outcome of bacteremia or death at 6 months post-TAVI.
详细描述
The PAPPI trial is designed as a prospective, crossover, unblinded, cluster randomized trial. The study includes all TAVI centers in Denmark. Each center will be included for either single dose cephalosporin (1st, 2nd or 3rd generation) plus a beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) or single dose of a cephalosporin (1st, 2nd or 3rd generation) as antibiotic prophylaxis in relation to TAVI. The antibiotic(s) will be given as a single dose intravenously per-procedural. Patients will be followed from date of TAVI procedure until 6 months post procedure.
The primary outcome of the PAPPI trial will be a composite of the following components within 6 months post TAVI:
- Bacteremia (excluding all enterobacterales)
- Death
Secondary outcomes will be each separate component of the primary outcome and will be ana-lyzed separately as time-to-first event analysis. Additional secondary outcomes will be;
- Bacteremia (excluding all enterobacterales)
- Acute kidney failure
- Death
- Length of hospital stay
- Days-out-of-hospital from TAVI to 6 months
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 预防
- 盲法
- 开放（无盲法）
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
- All patients > 18 years of age undergoing TAVI at sites in Denmark
排除标准
- Patients who do not want to participate and have chosen to "opt-out" of the trial
研究组 & 干预措施
Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis
Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis
干预措施: Beta-lactam antibiotic with spectrum for Enterococcus faecalis (Drug)
Cephalosporin (1st, 2nd, 3rd generation)
Cephalosporin (1st, 2nd, 3rd generation)
干预措施: Cephalosporin (Drug)
Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis
Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis
干预措施: Cephalosporin (Drug)
结局指标
主要结局
Number of patients with a composite outcome of bacteremia or death by 6 months.
时间窗: 6 months post-TAVI
Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI. Death is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI.
次要结局
- Days-out-of-hospital from TAVI to 6 months(6 months post-TAVI)
- Number of patients who died by 6 months(6 months post-TAVI)
- Bacteremia assessed by collection of blood cultures.(6 months post-TAVI)
- Number of patients with acute kidney failure assessed by plasma creatinine levels.(6 months post-TAVI)
- Length of hospital stay(From the day of TAVI-procedure until the day of discharge after the TAVI-procedure e.g. days from TAVI-procedure until discharge assessed up to 6 months post-TAVI due to end of follow-up.)
研究者
研究点 (6)
标识符
- NCT 编号
- NCT07442357
- 其他研究编号
- p-2025-19665
日期
- 首次提交
- (7个月前)
- 首次发布
- (7个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否