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

NCT ID: NCT06352554

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-08

Study Completion Date

2025-01-30

Brief Summary

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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

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Conditions

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Diagnosis Gonorrhea Resistance Bacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

Wellcome Trust

OTHER

Sponsor Role collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Australian Research Council Research Hub to Combat Antimicrobial Resistance

UNKNOWN

Sponsor Role collaborator

SpeeDx Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Nicole Lima

Role: CONTACT

+61 0292094170

Other Identifiers

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224842/Z/21/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

75A50122C00028

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023/ETH02474:STING

Identifier Type: -

Identifier Source: org_study_id

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