Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections

Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06352554

Acronym

STING

Enrollment

100

Registered

2024-04-08

Start date

2024-04-08

Completion date

2025-01-30

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Gonorrhea, Resistance Bacterial

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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

Measure	Time frame	Description
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	NG antibiotic susceptibility profile as determined by the InSignia assay compared to two other methods of NG AST - conventional culture via disc diffusion testing & E-test and genetic resistance testing via the ResistancePlus® GC (RPGC) IVD test (TGA, CE-IVD (IVDR) approved), developed by SpeeDx Pty Ltd.

Contacts

Primary ContactNicole Lima

nicolel@speedx.com.au+61 0292094170

Outcome results