DiagnosisSTINGNCT06352554
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
An observational study of Diagnosis and Gonorrhea, run by SpeeDx Pty Ltd.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Gonorrhea, Resistance Bacterial
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting with confirmed NG infections in one or both of the following anatomical sites: the urethra \& the rectum.
Who may be able to join
- Confirmed/suspected NG infection
- Willingness to give written informed consent as well as to participate in and comply with the study.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Diagnosis, Gonorrhea, Resistance Bacterial
- Medical subject headings
- Disease, Gonorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start8 Apr 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpeeDx Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust, German Federal Ministry of Education and Research, Australian Research Council Research Hub to Combat Antimicrobial Resistance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352554
- Sponsor's protocol ID
- 2023/ETH02474:STING
- Other IDs
- 224842/Z/21/Z, 75A50122C00028
- Acronym
- STING
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study
- ClinicalTrials.gov ID
- NCT06352554
- Acronym / sponsor ID
- STING / 2023/ETH02474:STING
- Conditions
- Diagnosis, Gonorrhea, Resistance Bacterial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SpeeDx Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust, German Federal Ministry of Education and Research, Australian Research Council Research Hub to Combat Antimicrobial Resistance
- Study start
- 8 Apr 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with confirmed NG infections in one or both of the following anatomical sites: the urethra \& the rectum.
Key inclusion criteria (2 listed)
- Confirmed/suspected NG infection
- Willingness to give written informed consent as well as to participate in and comply with the study.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis and Gonorrhea, run by SpeeDx Pty Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole Lima (+61 0292094170, nicolel@speedx.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.