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

Not yet recruiting

• Conditions: Resistance Bacterial; Diagnosis; Gonorrhea

• Registration Number: NCT06352554
• Lead Sponsor: SpeeDx Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-07
• Study Start: 2024-04-08
• Study First Posted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.