EUCTR2011-000158-47-AT进行中（未招募）不适用
Assessment of extracellular concentrations of linezolid and other currently approved antibiotics in patients presenting with severe bacterial lung infection
Klin. Abtlg. für Thorax- & Hyperbare Chirurgi0 个研究点目标入组 40 人开始时间: 2011年12月16日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent to participate in the study.
- •2. Conservative treatment options failed to work well
- •3. Male or female patient of 18 years of age or older.
- •4. Scheduled to undergo elective lung surgery
- •5. Suspected or proven severe bacterial infection
- •6. Severe sepsis according to ACCP/SCCP guidelines and criteria.
- •7. Negative urine pregnancy test in females of childbearing potential
- •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
排除标准
- •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.
- •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 unable or unwilling to adhere to the study-designated procedures and restrictions.
- •10. Breast-feeding women
- •11. Treatment with medications that inhibit monoamine oxidases A or B in the past two weeks.
- •12. Patients with uncontrolled hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder and acute state of confusion.
- •13. Treatment with serotonin reuptake inhibitors, tricyclic antidepressants or 5-hydroxytryptamine/serotonin1B/1D (5-HT1B/1D) agonists
研究者
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