Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Syphilis Clinical Trial

Official title:

Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03310424
• Other study ID #: 14423
• Status: Active, not recruiting
• Start date: October 27, 2017
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: August 2024
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Early infectious syphilis with exudative skin/genital lesions from which a lesion swab can be obtained

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Syphilis

Intervention

Other:
• No active intervention.
No active intervention is undertaken. Collection of samples for bio-informatic analysis only

Locations

Country	Name	City	State
United Kingdom	Mortimer Market Centre	London

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Genome Sequencing	Whole Genome Sequencing of T.pallidum	From samples collected at baseline
Primary	Host Transcriptomic Response	RNA Sequencing from lesion and blood samples	From samples collected at baseline