The Antibiotic Guardian Study- a Clinical Evaluation of a Rapid Diagnostic of Mycoplasma and Gonorrhoea Infections and Antibiotic Resistance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that are sexually active.
- •Patients that are symptomatic with:
- •Urethral discharge
- •Vaginal discharge
- •Rectal discharge
- •Dysparenia (pain during sex)
- •Pelvic pain
- •Testicular pain
- •Post-coital bleeding (bleeding after sex)
- •Vulval/Glans/Perianal pain.
排除标准
- •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.
结局指标
主要结局
Clinical evaluation of a novel, rapid diagnostic for the detection of Mycoplasma and Gonorrhoea
时间窗: 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.
次要结局
- Comparison of molecular tests and routine culture techniques for detection of antibiotic resistance in Gonorrhoea and Mycoplasma infections.(3 years)