CompletedNot Applicable

The Antibiotic Guardian Study- Clinical Evaluation of a Novel, Rapid Diagnostic for Gonorrhoea and Mycoplasma Infections.

United Kingdom160 participantsStarted 2019-10-01

Plain-language 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?

Who can participate

Age range

16 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients that are sexually active. * 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: * Pregnancy. * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea

Timeframe: 3 years

Trial details

NCT IDNCT05391035

SponsorCwm Taf University Health Board (NHS)

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-05-17

View on ClinicalTrials.gov More Sexually Transmitted Diseases, Bacterial trials