Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Host Transcriptomic Response
研究概览
简要总结
Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on the pathogenesis of syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches using molecular tests allow the immune response of the patient to infection to be measured directly from a swab of a genital ulcer or rash and/or a blood sample and also allow the whole genetic sequence of the bacteria to be obtained from a swab.
In this study the investigators will collect swabs from ulcers or rashes and a blood sample from patients with syphilis and measure both the response of the patient immune system and the genetic sequence of the bacteria. Patients will be enrolled at sexual health clinics in the United Kingdom. Patients will receive standard medical care including standard treatment for syphilis in line with national guidelines. Standard management already includes collection of a swab and a blood sample. For this study an additional swab sample and an additional 5ml of blood will be collected for use in this research project. By better understanding host immune system responds to infection with syphilis the studies aims to gain better insights in to the pathogenesis of this important sexually transmitted disease.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained
排除标准
- •Age <18 years
- •Unable to provide consent
- •Patients with other stages of syphilis apart from Primary or Secondary OR patients without a lesion from which swabs can be obtained
结局指标
主要结局
Host Transcriptomic Response
时间窗: From samples collected at baseline
RNA Sequencing from lesion and blood samples
Whole Genome Sequencing
时间窗: From samples collected at baseline
Whole Genome Sequencing of T.pallidum
次要结局
未报告次要终点
