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临床试验/NCT01140269
NCT01140269已完成不适用

Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients

American Burn Association8 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2010年5月30日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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