The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.
NCT ID: NCT05391035
Last Updated: 2024-05-20
Study Results
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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COMPLETED
160 participants
OBSERVATIONAL
2019-10-01
2024-05-17
Brief Summary
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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?
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients that are symptomatic with:
* Dysuria
* Urethral discharge
* Vaginal discharge
* Rectal discharge
* Dysparenia (pain during sex)
* Pelvic pain
* Testicular pain
* Post-coital bleeding (bleeding after sex)
* Vulval/Glans/Perianal pain.
Exclusion Criteria
* Aged under 16 years.
* Sexual assault case.
* Patients with very severe symptoms that need admission to a ward or referral for urgent gynaecology or urology interventions.
* Patients lacking capacity to consent.
16 Years
99 Years
ALL
No
Sponsors
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Cardiff University
OTHER
Cwm Taf University Health Board (NHS)
OTHER_GOV
Responsible Party
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Locations
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Cwm Taf Morgannwg University Health board
Llantrisant, Rhondda Cynon Taf, United Kingdom
Lucy Jones
Pontypridd, , United Kingdom
Countries
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Other Identifiers
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CT 269508
Identifier Type: -
Identifier Source: org_study_id
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