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

NCT06352554 | Not Yet Recruiting

• 3 other identifiers: 2023/ETH02474:STING224842/Z/21/Z75A50122C00028
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diagnosis; Gonorrhea; Resistance Bacterial

Outcome Measures

Primary Outcomes (1)

• 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 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.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Confirmed/suspected NG infection
• Willingness to give written informed consent as well as to participate in and comply with the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• SpeeDx Pty Ltd: lead
• Biomedical Advanced Research and Development Authority: collaborator
• Wellcome Trust: collaborator
• German Federal Ministry of Education and Research: collaborator
• Australian Research Council Research Hub to Combat Antimicrobial Resistance: collaborator

MeSH Terms

Conditions

Disease; Gonorrhea

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Nicole Lima

CONTACT

+61 0292094170; nicolel@speedx.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 8, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04