Randomized, Multicenter, Double-blind, Vancomycin-controlled Study to Evaluate the Efficacy of Ethanol Lock Solution for the Curative Treatment of Implantable Venous Access Port Infection Due to Coagulase-negative Staphylococci
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Recovery at 12 week following the lock solution treatment completion
研究概览
简要总结
Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in eradicating the staphylococcal biofilm in the port. Another disadvantage of Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does not expose to the risk of emergence resistance.
详细描述
Type of study: multi-center, randomized, double-blind, parallel-group, controlled clinical trial.
Number of centers: 9 French centers in Auvergne and Rhône-Alpes regions
Medical product Ethanol 40% + Enoxaparine 400UI/ml Versus Vancomycin 5 mg/ml + Héparine 2500UI/ml
Patients
Patients eligible for inclusion will be randomized to one of the two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Man or woman from 18 years old
- •With probable or definite implantable venous access port infection
- •With or without bacteraemia
- •Infection due to coagulase-negative staphylococci (except for lugdunensis Staphylococci)
- •Blood culture results available within 48 hours before inclusion
- •With health insurance
排除标准
- •Pregnant or breastfeeding woman
- •Allergy to ethanol
- •Patient with prosthetic cardiac valve
- •Necessity of venous access port withdrawal
- •Prior infection on the same venous access port
- •Patients under supervision or (legal) guardianship
研究组 & 干预措施
Experimental group
90 patients will receive 10 injections of ethanol lock solution in implantable venous access port during the first 10 days of the study.
干预措施: Ethanol 40% + Enoxaparine 400UI/ml (Drug)
control group
90 patients will receive 10 injections of vancomycin lock solution in implantable venous access port during the first 10 days of the study
干预措施: Vancomycine 5 mg/ml + Héparine 2500UI/ml (Drug)
结局指标
主要结局
Recovery at 12 week following the lock solution treatment completion
时间窗: at 12 week
Favorable evolution without complication up to the end of implantable venous access port use
时间窗: at 12 week
Favorable evolution without complication until the implantable venous access port withdrawal
时间窗: at 12 week
次要结局
- Negative peripheral and port blood cultures(at day 3 and day 10)
- Mortality due to infection of the port(at day 1)
- Implantable venous access port withdrawal rate(at day 1)
- Mechanical complication rate(at day 1)
- Blood alcohol concentration(30 min after the first lock solution treatment)
- Side effects evaluation(at day 1)