Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Prostatic concentration of ertapenem
研究概览
简要总结
The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.
详细描述
Ertapenem is an antibiotic belonging to carbapenems family and used in infections with Gram-negative bacilli with extended spectrum beta lactamase (ESBL). Its efficacy has been demonstrated in abdominal, soft tissue, pulmonary, skin and gynaecological infections. Recently it has been compared to ceftriaxone in urinary infections demonstrating his efficacy and tolerance.
The purpose of this study is to assess its benefit in probabilistic strategy by demonstrating its prostatic diffusion in significant concentration when administrated in a pre-operative single injection.
Patients were divided in two groups receiving a single injection of 1g of ertapenem 1h or 12h before endoscopic surgery of prostate hyperplasia.
Concentration of ertapenem was measuring on blood sample and on chips resection of prostate during endoscopic surgery.
To demonstrate the prostatic diffusion in significant amount of ertapenem, the prostatic concentration of ertapenem had to be higher than the minimal inhibitory concentration (MIC) for 40% of the time of injection interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Acceptance and understanding of the consent form (signed)
- •18-80 years old patients
- •BPH needing endoscopic resection according to French Urology Association recommendations
- •Procedure and follow up made in investigator center
- •normal digital rectal examination
- •patient > 69 years old, not necessary
- •patient < 69 years old, PSA<20 and if 4<PSA<20, the ratio free PSA/total PSA must be >10%
- •patient with renal clearance >60 estimated with MDRD
- •patient affiliated to the social security
排除标准
- •personal or familial history of prostatic or genito-urinary cancer
- •personal history of pelvic irradiation
- •personal history of hormone-therapy
- •personal history of prostatic adenomectomy by abdominal approach
- •personal history of allergy to beta-lactamines
- •urinary tract infection or bacterial colonisation at the time of procedure
- •carbapenems treatment in the two weeks before surgery
- •hyperresponsivness to ertapenem or other carbapenems antibiotic
- •patient with renal clearance estimated with MDRD <60
- •patient with catheter or probe permanently
研究组 & 干预措施
group A
One single perfusion of 1g of ertapenem 1 hour prior to prostate surgical resection
干预措施: Ertapenem (Drug)
group B
One single perfusion of 1g of ertapenem 12 hour prior to prostate surgical resection
干预措施: Ertapenem (Drug)
结局指标
主要结局
Prostatic concentration of ertapenem
时间窗: at the time of surgery
To observe whether a significant intra-prostatic concentration of ertapenem can be obtained after a pre-operative single administration.
次要结局
- Prostatic concentration of ertapenem(at the time of surgery)