EUCTR2014-004961-26-ES进行中（未招募）不适用
Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY): A Multi-Center Randomized Controlled Study Comparing Alternative Antibiotic Regimens in Patients Undergoing Tumor Resections with Endoprosthetic Replacements - PARITY
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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)Males and females 12 years of age or older;
- •2)Primary bone malignancies or benign aggressive tumors of the lower extremity, or soft-tissue sarcomas which have invaded the bone;
- •3)Treatment by excision and endoprosthetic reconstruction*; and
- •4)Provision of informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1)Current known Methicillin-Resistant Staphylococcus Aureus (MRSA), or Vancomycin Resistant Enterococcus (VRE) skin colonization*;
- •2)Documented anaphylaxis or angioedema to penicillin or the study antibiotic [cefazolin, or equivalent gram-positive coverage (i.e., cefuroxime)];
- •3)Prior surgery within the surgical field of the affected limb (excluding a biopsy)**;
- •4)Prior local infection within the surgical field of the limb**;
- •5)Current known immunologically-deficient disease conditions (not including recent chemotherapy) ***;
- •6)Known renal insufficiency with estimated creatinine clearance (eGRF) of less than 54 mL/min for drug clearance;
- •7)Reconstruction to include a structural allograft (bone transplant);
- •8)Likely problems, in the judgement of the investigator, with maintaining follow-up;
- •9)Enrolled or previously randomized in a competing study; and
- •10)Patients who weigh less than or equal to 45kg****
研究者
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