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临床试验/NCT06352554
NCT06352554尚未招募不适用

Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study

SpeeDx Pty Ltd0 个研究点目标入组 100 人开始时间: 2024年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics.

研究概览

简要总结

This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.

The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.

Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed/suspected NG infection
  • Willingness to give written informed consent as well as to participate in and comply with the study.

排除标准

  • Currently taking or having taken any antibiotics in the preceding 14 days
  • English fluency below level required to understand study procedures
  • Unwilling or unable to comply with study procedures

结局指标

主要结局

To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics.

时间窗: 1 year

Feasibility of using the InSignia assay to determine the antibiotic susceptibility of NG - from sample collection, handling \& transport to laboratory analysis \& data interpretation.

次要结局

  • To study the performance of the InSignia assay in determining antibiotic susceptibility of NG against commonly used & clinically relevant agents in clinical samples with comparison to gold standard methods.(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

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