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 (STING)
April 7, 2024 updated by: SpeeDx Pty Ltd
Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole Lima
- Phone Number: +61 0292094170
- Email: nicolel@speedx.com.au
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients presenting with confirmed NG infections in one or both of the following anatomical sites: the urethra & the rectum.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
Time Frame: 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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 8, 2024
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
January 30, 2025
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 8, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 7, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/ETH02474:STING
- 224842/Z/21/Z (Other Grant/Funding Number: Wellcome Trust)
- 75A50122C00028 (Other Grant/Funding Number: HHS/BARDA OTA Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.