NCT06448624已完成4 期
Effect of Single Dose & Intrapocket Prophylactic Antibiotic to Cardiac Implantable Electronic Device-related Infection & Biomarkers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of CIED-related infection
研究概览
简要总结
Effect of single dose & intrapocket prophylactic antibiotic to cardiac implantable electronic device-related infection & biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of CIED implantation
- •No infection at the time of implantation
排除标准
- •Refuse to participate in the study
- •Allergy to ampicillin sulbactam
- •CIED debridement
研究组 & 干预措施
Intervention
Placebo Comparator
Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + placebo for 3 days after implantation
干预措施: Placebo 3 days (Drug)
Control
Experimental
Ampicillin sulbactam 1.5 gram IV preimplantation + ampicillin sulbactam 1.5 gram intrapocket + ampicillin sulbactam 1.5 gram IV BID for 3 days after implantation
干预措施: Ampicillin sulbactam 3 days (Drug)
结局指标
主要结局
Incidence of CIED-related infection
时间窗: Baseline, 3 days, 7 days, and 28 days
Incidence of superficial infection, pocket infection, infective endocarditis, or rehospitalization
次要结局
- Level of Presepsin(Baseline and 24 hours after CIED implantation)
- Level of Interleukin-6(Baseline and 24 hours after CIED implantation)
- Level of Procalcitonin(Baseline and 24 hours after CIED implantation)
研究者
Pipin Ardhianto
Principal investigator
Universitas Diponegoro
研究点 (1)
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