Penetration of Ertapenem Into Bone in Patients With Diabetes Mellitus or Peripheral Vascular Diseases Who Underwent Bellow Knee Amputation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- blood,tissue and bone drug levels
研究概览
简要总结
The aim of the study is to determine the penetration levels of ertapenem into bone tissues in patients with Diabetes Mellitus (D.M) or Peripheral Vascular Diseases (P.V.D) undergoing amputation, and to correlate theme to the concentration of the drug in blood and other soft tissues
详细描述
Twelve patients with D.M or P.V.D who are undergoing bellow knee amputation with or without gangrene.
Within four weeks prior the amputation a vascular profile will be determined by Doppler and skin perfusion will be determined by transcutaneous oxygen pressure measurements (TcPO2) on the dorsal side of the mid foot of the affected limb.
Each patient will receive 1 g of Ertapenem in 100 ml of normal saline by IV infusion -during 30 minutes through IVAC:
- -2 days prior the amputation
- -1 day prior the amputation
- 1 hour before amputation The infusions will be started approximately at the same time of the 3rd infusion, prior the planned amputation.
Blood samples (approximately 6ml each) will be collected before Ertapenem administration, simultaneously with bone and soft tissue samples at the time of amputation and at the end of the surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Diabetes Mellitus or Peripheral Vascular Disease
- •Undergoing bellow knee amputation with or without gangrene
- •Patients without clinical signs of acute infection
- •Creatinine Clearence more than 60 cc/ min
排除标准
- •Known hypersensitivity to any component of ertapenem or to other drugs in the same class.
- •Patients who have demonstrated anaphylactic reactions to beta-lactams.
- •CNS disorders (e.g., brain lesions or history of seizures).
- •Patient treated with other antibiotics at least 72 hours.
- •Pregnant women, nursing women, or fertile women not practicing adequate methods of contraception.
- •Patient or legal representative of the patient is unable to provide written informed consent for any reason.
- •Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient.
- •Neutropenia
- •Renal failure
- •Hepatic Insufficiency: > x 2 upper limit.
- •A need for any additional concomitant systemic antibacterial agent.
- •Life expectancy less than 6 month
- •Patient is undergoing immunosuppressive therapy, including use of high dose corticosteroids (e.g.,20 mg or more prednisone or equivalent per day)
- •Patient is in a situation or has a condition which, in the investigator's opinion, may interfere with optimal participation in the study.
- •Participation in an another clinical trial.
结局指标
主要结局
blood,tissue and bone drug levels
时间窗: 3 days each patient
次要结局
未报告次要终点