Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- SpeeDx Pty Ltd
- Enrollment
- 100
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Confirmed/suspected NG infection
- •Willingness to give written informed consent as well as to participate in and comply with the study.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Secondary Outcomes
- 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)