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
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
- 否
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)
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)
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)
