Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

NCT03310424 | Unknown

• 1 other identifier: 14423
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Syphilis

Outcome Measures

Primary Outcomes (2)

• Whole Genome Sequencing

  Whole Genome Sequencing of T.pallidum

  From samples collected at baseline

• Host Transcriptomic Response

  RNA Sequencing from lesion and blood samples

  From samples collected at baseline

Interventions

No active intervention. OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead

Study Sites (1)

Mortimer Market Centre

London, WC1E 6JB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Lesion Swab samples

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 16, 2017
• Study Start: October 27, 2017
• Primary Completion: July 30, 2019
• Study Completion: August 1, 2024
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)