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OpenTrials
Completed

NCT Number: NCT03709862

Global Syphilis Sequencing

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 syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab.

In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Birmingham, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of syphilis

Exclusion criteria

  • No PCR positive clinical sample

Treatment and study plan

Whole genome sequencing

Diagnostic Test

Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis

Primary outcomes

  1. Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage

    Time frame: Measured at baseline - time of enrollment. There are no further samples or visits in the study.

    Whole genome sequencing of UK and global syphilis samples combined with phylogenomic and population genomic analyses to determine the population structure and diversity of Treponema both regionally and in global context. Diversity will be assessed by measuring nucleotide diversity between samples and reference genomes.

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Wellcome Sanger Institute

Registry information

Official study title

Whole Genome Sequencing of Syphilis Using Routine Clinical Samples

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Oct 17, 2018
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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