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临床试验/NCT02102087
NCT02102087已完成不适用

A Matched, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination When Compared to Laboratory Standard Procedures

Magnolia Medical Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 971 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
971
试验地点
2
主要终点
Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)

研究概览

简要总结

This is a matched, 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 peripheral venipuncture 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
Non 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 candidate for direct-to-media (DTM) technique

研究组 & 干预措施

Initial Specimen Diversion Device (ISDD)

Experimental

The ISDD will be used in conjunction with standard blood culture bottles.

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

Lab standard practice (LSP)

Active Comparator

A standard blood culture kit will be used.

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

结局指标

主要结局

Rate of blood culture contamination when using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP)

时间窗: Baseline

Comparison of contamination for each clinical episode. The proportions of discordant contamination episodes will be compared between the Initial Specimen Diversion Device and Lab Standard Practice using McNemar's test.

次要结局

  • Occurrence rate of 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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