Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03709862
Other study ID # 16014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2018
Est. completion date February 28, 2022

Study information

Verified date April 2022
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 726
Est. completion date February 28, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of syphilis Exclusion Criteria: - No PCR positive clinical sample

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Whole Genome Sequencing
Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis

Locations

Country Name City State
United Kingdom University Hospitals Birmingham Birmingham
United Kingdom Brighton and Sussex NHS Trust Brighton
United Kingdom Leeds University Teaching Hospital Leeds
United Kingdom Mortimer Market Centre London
United Kingdom Penine Acute Hospitals Trust Manchester

Sponsors (2)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Wellcome Sanger Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage 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. Measured at baseline - time of enrollment. There are no further samples or visits in the study.
See also
  Status Clinical Trial Phase
Completed NCT03660488 - Cefixime for Alternative Syphilis Treatment Phase 2
Recruiting NCT05548426 - Linezolid for Syphilis Pilot Study Phase 2
Completed NCT02191527 - Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique N/A
Completed NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Terminated NCT01540227 - Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.
Completed NCT02257658 - Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM N/A
Completed NCT02611765 - Syphilis Response to Higher Penicillin Dosage: The 2.4 Versus 7.2 Study Phase 4
Not yet recruiting NCT06428643 - A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities N/A
Completed NCT03637660 - Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection Phase 4
Active, not recruiting NCT03310424 - Transcriptomic and Next Generation Sequencing Approaches to Infection With Treponema Pallidum
Completed NCT00207506 - Lay Health Advisors for Sexually Transmitted Disease Prevention Phase 1/Phase 2
Completed NCT00213018 - Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission Phase 2
Recruiting NCT06059443 - mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention N/A
Completed NCT04480749 - Syphilis Self-testing to Expand Test Uptake Among Men Who Have Sex With Men (SST) Phase 4
Not yet recruiting NCT06058286 - MENJAGA: Continuous Quality Improvement for Antenatal HIV, Syphilis and Hepatitis B Testing in Indonesia N/A
Active, not recruiting NCT03980223 - Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men Phase 4
Completed NCT01465607 - Implementation of an Efficacious Intervention for High Risk Women in Mexico N/A
Completed NCT00553111 - Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission N/A
Active, not recruiting NCT06367621 - Retrospective Study of iStatis Syphilis Ab Test (POC)
Completed NCT02454816 - Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia N/A