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NCT06352554 Clinical Trial

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

Diagnosis Clinical Trial

— STING  

Official title:
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06352554
Other study ID # 2023/ETH02474:STING
Secondary ID 224842/Z/21/Z75A
Status Not yet recruiting
Phase
First received
Last updated
Start date April 8, 2024
Est. completion date January 30, 2025

Study information
Verified date April 2024
Source SpeeDx Pty Ltd
Contact Nicole Lima
Phone +61 0292094170
Email nicolel@speedx.com.au
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date January 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (5)
Lead Sponsor Collaborator
SpeeDx Pty Ltd Australian Research Council Research Hub to Combat Antimicrobial Resistance, Biomedical Advanced Research and Development Authority, German Federal Ministry of Education and Research, Wellcome Trust

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Feasibility of using the InSignia assay to determine the antibiotic susceptibility of NG - from sample collection, handling & transport to laboratory analysis & data interpretation. 1 year
Secondary 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. 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. 1 year
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