Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12,814
- 试验地点
- 1
- 主要终点
- Hospitalization attributed to device infection
研究概览
简要总结
The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.
详细描述
This is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. Centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. Patients will not be randomized. Centres will be randomized to one therapy and then cross over to the next after 6 months. At one year they will randomize again and then cross over for the final time at 18 months. During each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure.
Ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). A third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18 years
- •Received one of the following procedures:
- •A second or subsequent procedure on the arrhythmia device pocket:
- •ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement
- •Pocket or lead revision
- •System upgrade (insertion or attempted insertion of leads)
- •New cardiac resynchronization therapy device implant (pacemaker or ICD)
- •Patient is not known to have device infection at the time of the surgery
排除标准
- 未提供
研究组 & 干预措施
Conventional
Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
干预措施: Conventional (Drug)
Incremental
Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
干预措施: Incremental (Drug)
结局指标
主要结局
Hospitalization attributed to device infection
时间窗: Evaluation is one year post patient's procedure
次要结局
- 1. Proven device infection not requiring surgical intervention (medically treated device infection).(Up to one year post procedure)
- 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.(Up to one year post procedure)
- 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.(Up to one year post procedure)
- Cost benefit analysis(At completion of data collection period)
- 2. Any treatment with antibiotics for suspected device infection.(Up to one year post procedure)
- 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).(Up to one year post procedure)