Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 8
- 主要终点
- Correlation of PCR results with blood culture results
研究概览
简要总结
The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.
详细描述
Burn patients have lost their primary barrier to microorganism invasion and therefore are continually and chronically exposed to pathogens. Ninety-seven percent of patients with >20% total body surface area (TBSA) burns develop septicemia; predominantly involving gram positive cocci including MRSA and methicillin sensitive Staphylococcus aureus. Blood culture (BC) is the traditional detection method for septicemia. However, antibiotics and inadequate sample volumes can impair detection by BC and results can take 3-4 days.
Polymerase chain reaction (PCR) represents a potential adjunct to BC. Pathogens are detected in a growth-independent manner by targeting their genetic make-up. Quantitative determining of pathogen DNA using PCR could aid in determining antimicrobial drug therapy efficacy by providing results on the same testing day as opposed to 3-4 days with BC. PCR may also detect persistent infections during antimicrobial therapy when culture samples are inhibited.
The aims of this study are:(1)to correlate quantitative PCR results with that of the BC; (2) to test the clinical application of PCR results with clinical outcomes of treatment of presumptive diagnosis of staphylococcal sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20% or > TBSA burns at hospital admission
- •will require BC during hospital stay
- •Patient/surrogate able to sign consent
排除标准
- •allergic to nafcillin, cefazolin, vancomycin, linezolid, and/or daptomycin
- •on antibiotic(s) prior to first BC
结局指标
主要结局
Correlation of PCR results with blood culture results
时间窗: 72 hours after positive blood culture results
次要结局
- Duration of signs of infection(14 days after the administrationof anti-Staphylococcus therapy)
- Duration of antibiotic use(14 days after administration of antimicrobial therapy)
- Correlation of PCR result with mortality(Day 28 of intensive care unit stay)
