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临床试验/NCT02093494
NCT02093494终止不适用

A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)

Magnolia Medical Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
2
主要终点
Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC

研究概览

简要总结

This is a randomized, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults >19 years old

排除标准

  • Not a good candidates for direct-to-media (DTM) technique

研究组 & 干预措施

Initial Specimen Diversion Device (ISDD)

Experimental

The ISDD will be used to collect the blood culture.

干预措施: Initial Specimen Diversion Device (ISDD) (Device)

Lab standard practice (LSP)

Active Comparator

The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.

干预措施: Lab standard practice (LSP) (Procedure)

Lab standard practice (LSP)

Active Comparator

The ISDD will not be used to collect the blood culture. Standard blood culture specimen collection kits will be utilized.

干预措施: Peripheral Intravenous Catheters (PIVC) (Device)

结局指标

主要结局

Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC

时间窗: Baseline

次要结局

  • Evaluate the occurrence of any adverse device effects(Baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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