Target site pharmacokinetics of linezolid after repetitive doses in diabetic patients with bacterial foot infection

Medical university Graz, Department of Plastic Surgery0 个研究点开始时间: 2009年2月10日最近更新: 2016年11月7日

适应症

试验速览

暂无简介。

•1. Written informed consent to participate in the study
•2. Male or female patient of 18 years of age or older
•3. Patient suffers from documented diabetes and soft tissue infection of the lower limb complicated by osteomyelitis
•4. Patient requires surgical debridement with bone resection and intravenous anti-microbial therapy
•5. Negative urine pregnancy test in females of childbearing potential
•6. Patient is willing to participate in the study, follow protocol study treatment regimen, and comply with all planned assessments.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Treatment with the study drug within the past three weeks prior to study enrolment.
•2. Relevant renal dysfunction indicated by a creatinine clearance = 40 ml/min as determined by the Cockcroft-Gault equation using actual body weight (Appendix 4).
•3. Severe hepatic impairment defined by a serum AST = 150.
•4. Neutrophil count <1000/µl
•5. Thrombocytopenia < 50 000 /µl
•6. HIV, HCV or HBV infection.
•7. History of hypersensitivity to the study drug or to drugs with similar chemical structures (oxazolidinones).
•8. Treatment with antidepressants belonging to the class of selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenalin reuptake inhibitors (SNRIs)
•9. Patients submitted to the hospital with known pathogens resistant to study drug
•10. Use of any other investigational therapy at the time of enrolment, or within 30 days.
•11. Patients unable or unwilling to adhere to the study-designated procedures and restrictions.
•12. Unable to understand the nature, purpose and extent of the study
•13. Breast-feeding woman

发起方

Medical university Graz, Department of Plastic Surgery