Are Mycoplasma Species Associated With Disease in the Genitourinary System of Male and Female Patients Attending Sexual Health Clinics or Are They Bacterial Commensals?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- M. hominis and disease
研究概览
简要总结
The purpose of this study is to determine if the presence of Mycoplasma hominis bacteria is associated with Bacterial vaginosis (BV), non-gonococcal urethritis (NGU) or vaginitis in patients attending sexual health clinic. Patients were participants of the MYCO WELL D-ONE study. Ethics for this follow-on pathway-to-portfolio study (IRAS:253889) is now approved by NRES and HCRW.
The important primary aim of this study is to determine if Mycoplasma hominis (M.hominis) is associated with BV, NGU and vaginitis in the genitourinary system of patients or if they are bacterial commensals. This is important proof of concept work. The secondary aim for this research is to determine if there are clinical and social parameters that are associated with Mycoplasma infection.
Preliminary analysis of 100 patients yielded pilot data suggesting M.hominis is strongly associated with BV, NGU and vaginitis. We aim to consolidate these findings by expansion to 1000 patients from our completed MYCOWELL D-ONE study.
详细描述
The clinical study site is The Department of Sexual Health, Dewi Sant Hospital, Cwm Taf University Health Board. This study will retrospectively examine the clinical notes of consented participants (IRAS project ID:253889) in the MYCO WELL D-ONE study (IRAS project ID:230693).
Notes will be identified by the sexual health clinic number. The clinic proforma records the following parameters:
- Gender the patient identifies with
- Age of the patient when the MYCO WELL D-ONE study sample collected
- Symptoms and signs that were recorded in the patient notes e.g. BV/NGU
- Previous sexually transmitted infections diagnosed
- Drug history
- Treatments the patient received
- Sexual history e.g. type of sexual activity On completion, he parameters associated with positive M.hominis result; bacteria load quantification/antimicrobial resistance) and statistical analysis will be examined as below. I Statistical analysis This will be performed on anonymised data. The primary outcome measure of this study is to determine if M.hominis is associated with BV, NGU and vaginitis in the genitourinary system of patients or if it is a bacterial commensal. The secondary outcome for this research is to determine if there are clinical and social parameters that are associated with M.hominis infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sexually active participants aged 18 to 100 years
- •Participants can give informed consent in writing.
排除标准
- •Patients who have been sexually assault.
- •Participants who cannot give informed consent in writing.
结局指标
主要结局
M. hominis and disease
时间窗: 6 months
Number of symptomatic participants with Mycoplasma infections
次要结局
- M.hominis and commercial sex workers(6 months)
- M.hominis and chemsex(6 months)
- M.hominis and drug use(6 months)
- M.hominis and abortion(6 months)
- M.hominis and anal sex(6 months)
- M.hominis and unprotected sex(6 months)
- M.hominis and contraception(6 months)
- M.hominis and number of sexual contacts(6 months)
- M.hominis and men who have sex with men(6 months)
- M.hominis and miscarriage(6 months)