跳至主要内容
临床试验/NCT00698919
NCT00698919Unknown不适用

Bacterial DNA Detection as a Diagnostic Tool of Infection in Critical Ill Patients With SIRS

Delafontaine Hospital5 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
5
主要终点
Using PCR we will determine the accuracy of these tests in identifying bacteria or fungi responsible of the infection.

研究概览

简要总结

Sepsis is a common cause of morbidity and death in intensive care units. Clinical and laboratory signs of systemic inflammation, including changes in body temperature, tachycardia, or leukocytosis, are neither sensitive nor specific enough for the diagnosis of sepsis. The diagnosis of sepsis is difficult, because clinical signs are unspecific. These signs include tachycardia, leucocytosis, tachypnoea, and pyrexia, which are collectively termed a systemic inflammatory response syndrome (SIRS). SIRS is very common in critically ill patients, being found in various conditions including trauma, surgery, burns, pancreatitis, post-cardiac arrest syndrome, cardiac surgery. Microbiological culture can be used to distinguish sepsis from non-infectious conditions. However, this method lacks sensitivity and specificity, and there is often a substantial time delay. So these signs can also be misleading because critically ill patients often present with the systemic inflammatory response syndrome without infection. This issue is of paramount importance, since therapy and outcome differ greatly between patients with and those without sepsis; clinicians are often prone to overuse antibiotic therapy being afraid of not treating a potential infection or superinfection. Moreover, the widespread use of antibiotics for all such patients is likely to increase antibiotic resistance, toxicity, and costs. On the opposite, any delay in administration of antibiotics can be extremely detrimental for the infected patient with an exponential increase of the odd ratio for death. Search for early biomarker tools for the diagnosis of infection, initially promising, are quite challenged and controversial nowadays because they can be more related to the inflammation response, irrespective to the insult. Furthermore up to 40% of the infections remain strongly suspected but not bacteriologically documented. Persisting researches are ongoing to find new markers to better discriminate SIRS related to infection process from to SIRS not related to infection. Cytokine profiles using multiplex analysis seems more related to the severity of the SIRS than the trigger of the SIRS (infectious or non infectious diseases). Thus, new tools have been developed to identify bacteria by detecting their DNA by various techniques. These techniques have many potential interests over conventional microbiologic tests by decreasing turnaround time (within a few hours 2-6 hours), reducing inhibitory effects of prior use of antibiotics, detection of slow or fastidious growing organisms. However these tests remain to be validated in a clinical setting.

The goal of the current study is to evaluate the diagnostic value of plasma detection of bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.

详细描述

The goal of the current study is to evaluate the diagnostic value of plasma detection of bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.

Definitions of septic syndromes based from the ACCP/SCCM expert panel. Terms Definition criteria Infection Invasion by microorganisms of an normally sterile tissue

Systemic inflammatory response Syndrome (SIRS) At least 2 of 4 following criteria:

  • Temperature > 38°C or < 36°C
  • Heart Rate > 90 beat/min
  • Tachypnea > 20/min or PaCO2 < 32 mmHg
  • WBC count > 12 000/mm3 or < 4 000/mm3 Sepsis SIRS related to an infectious process

Severe Sepsis Sepsis with :

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least SIRS criteria at admission or during ICU stay.

排除标准

  • age <18 year old.

结局指标

主要结局

Using PCR we will determine the accuracy of these tests in identifying bacteria or fungi responsible of the infection.

时间窗: End of the ICU stay

次要结局

  • We will examine whether or not cytokines' profile, levels of endotoxin and peptidoglycan help to discriminate infectious from non-infectious SIRS.(The assays will be done later on (within 6 months))

研究者

发起方
Delafontaine Hospital
申办方类型
Other

研究点 (5)

Loading locations...

相似试验

Bacterial Infection Diagnosis Using Blood DNA | 临床试验