An observational study in Diagnosis, Gonorrhea and Resistance Bacterial, sponsored by SpeeDx Pty Ltd. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by SpeeDx Pty Ltd · Observational
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.
1,382 studies on the registry are indexed under Disease; 612 are open to participants now.
This study's planned enrollment of 100 is below the median of 209 across 598 observational studies indexed under Disease.
Browse Disease studies →This is the only study on the registry with SpeeDx Pty Ltd as lead sponsor.
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Patients presenting with confirmed NG infections in one or both of the following anatomical sites: the urethra \& the rectum.
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Exclusion Criteria:
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.
Time frame: 1 year
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.
Time frame: 1 year
No study locations are listed for this record.
Start is estimated for Apr 2024; primary completion for Dec 2024, 8 months later.
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This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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