The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.
Study Details
Study Description
Brief Summary
Primary research question:
Are novel molecular tests for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance sensitive and specific in symptomatic patients attending a sexual health clinic?
Secondary research question:
Are novel molecular tests for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This clinical study aims to clinically evaluate a novel, rapid molecular diagnostic for Mycoplasma and Gonorrhoea infections. This diagnostic detects both infection and also detects any antimicrobial resistance. These tests detect these organisms and provide information about antimicrobial resistance in a laboratory, but are not widely used in sexual health clinics in the UK and have not been clinically evaluated in symptomatic patients in detail.
Our primary objective is to determine if the novel molecular test for rapid detection of Mycoplasma and Gonorrhoea infections and antimicrobial resistance is sensitive and specific in symptomatic patients attending a sexual health clinic.
Our secondary research objective is to determine whether the novel molecular test for detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections more accurate than standard laboratory culture techniques.
Eligible participants will be aged between 16 and 99 years and attend a sexual health clinic at Cwm Taf Morgannwg Sexual Health department. They will be symptomatic.
Participants will have routine swabs performed as per routine sexual health care, following gaining participant consent in writing. Waste urine and discharge from vaginal swabs will be utilised in the study. Samples will be given a unique study number and sent to the normal NHS laboratory for analysis as per routine care. Left-over samples of urine and swabs will be pseudo-anonymised and then transported to the academic laboratory for analysis with the novel diagnostic with the unique study ID.
Results from routine tests for Mycoplasma and Gonorrhoea detection and for antimicrobial resistance will be compared to results of the novel diagnostic.
This study has had a substantial amendment reviewed and passed by an ethics committee, due to COVID disruptions in healthcare. It has changed from an interventional study to an observational study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Symptomatic patients attending a sexual health clinic. A cohort of 160 symptomatic people attending a sexual health clinic in the UK will be recruited to this observational study. |
Outcome Measures
Primary Outcome Measures
- Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea [3 years]
Investigators will determine the specificity and sensitivity of the novel molecular diagnostic in the detection of Mycoplasma and Gonorrhoea infections from clinical samples performed during testing of symptomatic participants. Results of the novel diagnostic will be compared to standard current laboratory test results and the results of quantitative PCR.
Secondary Outcome Measures
- Comparison of molecular tests and routine culture techniques for detection of antibiotic resistance in Gonorrhoea and Mycoplasma infections. [3 years]
Investigators will determine the specificity and sensitivity of the novel molecular diagnostic in the detection of antimicrobial resistance in Mycoplasma and Gonorrhoea infections from clinical samples performed during testing of symptomatic participants. Results of the novel diagnostic will be compared to standard current laboratory test results for antibiotic resistance and and the results of sequencing Gonorrhoea and Mycoplasma bacteria for antibiotic resistance genes.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients that are sexually active.
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Patients that are symptomatic with:
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Dysuria
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Urethral discharge
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Vaginal discharge
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Rectal discharge
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Dysparenia (pain during sex)
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Pelvic pain
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Testicular pain
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Post-coital bleeding (bleeding after sex)
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Vulval/Glans/Perianal pain.
Exclusion Criteria:
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Pregnancy.
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Aged under 16 years.
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Sexual assault case.
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Patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions.
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Patients lacking capacity to consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cwm Taf Morgannwg University Health board | Llantrisant | Rhondda Cynon Taf | United Kingdom | CF82 7XR |
| 2 | Lucy Jones | Pontypridd | United Kingdom | CF37 1LB |
Sponsors and Collaborators
- Cwm Taf University Health Board (NHS)
- Cardiff University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT 269508