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)
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
- 否
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)
The ISDD will be used to collect the blood culture.
干预措施: Initial Specimen Diversion Device (ISDD) (Device)
Lab standard practice (LSP)
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)
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)
