Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum

Sponsor
London School of Hygiene and Tropical Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03310424
Collaborator
(none)
46
1
57.1
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No active intervention.

Study Design

Study Type:
Observational
Anticipated Enrollment :
46 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
Actual Study Start Date :
Oct 27, 2017
Actual Primary Completion Date :
Jul 30, 2019
Anticipated Study Completion Date :
Aug 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Whole Genome Sequencing [From samples collected at baseline]

    Whole Genome Sequencing of T.pallidum

  2. Host Transcriptomic Response [From samples collected at baseline]

    RNA Sequencing from lesion and blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mortimer Market Centre London United Kingdom WC1E 6JB

Sponsors and Collaborators

  • London School of Hygiene and Tropical Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT03310424
Other Study ID Numbers:
  • 14423
First Posted:
Oct 16, 2017
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022