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临床试验/NCT00645619
NCT00645619撤回不适用

Use of a Novel Protein (sTREM-1) to Differentiate Pure Viral Lung Infection From Viral With Co-existing Bacterial Lung Infection

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家开始时间: 2008年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
TREM-1 level in the BAL fluid of patients with pure viral pneumonia in comparison to patients with viral with co-existing bacterial pneumonia

研究概览

简要总结

The purpose of this study is to determine whether a protein called TREM-1 can be used to differentiate viral and bacterial pneumonias in children who are on ventilator support. We propose that the level of TREM-1 will be significantly elevated in the lung fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.

详细描述

Most often, viruses are the cause of pneumonia in children. However, viral pneumonias are frequently associated with secondary bacterial pneumonia. It is important, though difficult, to differentiate patients who only have viral pneumonia from those who have viral pneumonia with secondary bacterial pneumonia. This will help physicians to prescribe antibiotics to only those with bacterial pneumonia and avoid antibiotic use in those with pure viral pneumonia, thus help to limit health-care cost and to decrease emergence of antibiotic resistance. In adult studies, TREM-1 has been shown to be specifically expressed in bacterial infections.

We propose that measuring TREM-1 in the bronchoalveolar lavage (BAL) fluid will help to differentiate these groups. Our hypothesis is that concentration of TREM-1 will be significantly elevated in the BAL fluid of children with bacterial pneumonia and viral with co-existing bacterial pneumonia than in children with pure viral pneumonia.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Children from birth to 18 years intubated for respiratory failure or for surgery as mentioned above within 48 hours of intubation.

排除标准

  • Use of antibiotics >72 hours preceding the study (not applicable to the definite bacterial pneumonia group)
  • Use of oral/parenteral glucocorticoid therapy <2 weeks prior to admission
  • Presence of tracheostomy
  • Active treatment for pulmonary arterial hypertension
  • Mechanical ventilation with FIO2 >0.6, MAP>20
  • Presence of severe pulmonary interstitial emphysema, pneumothorax, bradycardia (heart rate, <80 beats/min in neonates, <70 beats/min in infants), hypotension (mean arterial pressure, <40 mm Hg in neonates, <50 mm Hg in infants), and platelet count of <30,000/mm
  • Immunodeficient or immunocompromised due to other conditions.
  • Enrollment in another interventional study that employs BAL.

结局指标

主要结局

TREM-1 level in the BAL fluid of patients with pure viral pneumonia in comparison to patients with viral with co-existing bacterial pneumonia

时间窗: Within 48 hours of being intubated

次要结局

  • TREM-1 level in the BAL fluid of patients with pure bacterial pneumonia and no pneumonia(Within 48 hours of intubation for TREM-1 level)
  • TREM-1 level in the serum of all 4 groups(Within 48 hours of intubation for TREM-1 level)
  • Length of ventilator support, length of ICU and hospital stay(Within 48 hours of intubation for TREM-1 level)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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