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临床试验/NCT01985737
NCT01985737已完成不适用

Biofilm Microbiome and Microbial DNA Load in Neonatal Catheter-associated Bloodstream Infections

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2013年11月1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
144
试验地点
1
主要终点
Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI

研究概览

简要总结

Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into blood vessels of premature babies (neonates) to give them nutrition and medications. Sometimes these tubes get infected and they need to be removed. Also, the babies need to be given medications to treat these infections (antibiotics). PICC infections in neonates are a serious problem and we need to find new ways of detecting infections early so that we can treat them promptly to avoid complications.

The purpose of this study is to understand what causes tube infections in neonates and to develop a test to detect tube infections early to avoid complications.

详细描述

Catheter-associated bloodstream infections (CLABSIs) are a significant component of healthcare-associated infections (HAI),which are associated with significant mortality, morbidity and healthcare costs. Neonates are at higher risk for CLABSIs than children or adults and CLABSIs are seen more commonly in neonatal than pediatric or adult intensive care units. Neonates, who develop CLABSIs, are not only at serious risk for mortality but also long term neurodevelopmental impairment. CLABSIs are often caused by organisms colonizing the skin and the most frequently isolated organisms are CONS, S. aureus and Candida.

The catheter biofilm microbiome, to our knowledge has not been investigated before. Evaluation of biofilm microbial signatures and microbial DNA load is a novel strategy that may permit earlier diagnosis of CLABSIs. Earlier detection may enable earlier targeted therapy such as antimicrobial lock solutions and may facilitate preservation of catheters in this vulnerable population. Catheter microbial DNA signatures or load may be useful biomarkers to not only predict or diagnose infections but to monitor antibiotic therapy and to confirm resolution of infection.

We will study 15 percutaneously inserted central catheters (PICC) each from neonates with CLABSIs and those without. We will evaluate the bacterial microbiome by profiling V3-5 region of the 16S rDNA, by PCR and pyrosequencing. We will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site. We aim to identify microbial signatures that predispose to dissemination of infection from catheter biofilms leading to CLABSIs. Further, we will quantify microbial DNA load in blood from the catheters at the time of removal, by real-time PCR of the bacterial 16S rDNA.

研究设计

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

入排标准

年龄范围
1 Day 至 3 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates with a percutaneously inserted central catheters (Neo PICC) who may or may not develop CLABSIs

排除标准

  • Infants with known Immunodeficiency Syndrome

结局指标

主要结局

Determine the differences in the catheter biofilm microbiome from neonates with CLABSIs compared to those without CLABSI

时间窗: 1 year

We will study catheters from neonates with CLABSIs and those without. We will correlate the catheter biofilm microbiome with catheter tip cultures and the skin microbiome at the catheter entry site.

次要结局

  • Determine the diagnostic accuracy of microbial DNA load for the detection of catheter infection(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Pammi

Assistant Professor

Baylor College of Medicine

研究点 (1)

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