跳至主要内容
临床试验/NCT03310424
NCT03310424进行中(未招募)不适用

Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年10月27日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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