How syphilis is transmitted between sexual partners is unclear. Asymptomatic detection i.e. detection of syphilis bacteria (Tp) from anatomical sites without lesions, in patients with syphilis infection, suggests that asymptomatic transmission from these sites may play a role. However, no existing studies have established whether the syphilis bacteria (Tp) detected was viable. This means it is not known if the bacteria at this anatomical site is alive and therefore able to transmit the infection. Further, studies have focused mostly on men who have sex with men, resulting in a lack of evidence regarding anal shedding in men-who-have-sex-with-women only and women (regardless of sexual behaviour), and no data on asymptomatic vaginal shedding in women. This study will explore: 1. Patterns of Tp detection in women and men-who-have-sex-with-women only. 2. Whether detected Tp from each asymptomatic anatomical sites is viable 3. Duration of Tp detection and viability (alive and transmissible bacteria). Patients presenting to a participating sexual health service (overseas only) for management of suspected/confirmed early infectious syphilis will be eligible. During the routine clinical examination, participants will have additional oral and anal swabs, urine, vaginal swab (where relevant), penile skin swab (where relevant) and blood sample collected, in addition to the routine samples taken from the same sites and routine serology collected when syphilis is diagnosed.
Study Type
OBSERVATIONAL
Enrollment
480
No intervention: Observational study
Monash University
Melbourne, Victoria, Australia
ACTIVE_NOT_RECRUITINGXinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGFoundation for Professional Development
Pretoria, South Africa
NOT_YET_RECRUITINGBurrell Street Clinic, Guy's and St Thomas'
London, United Kingdom
RECRUITINGJefferiss Clinic St Mary's Hospital, Imperial College London
London, United Kingdom
NOT_YET_RECRUITINGMortimer Market Centre
London, United Kingdom
RECRUITINGLondon School of Hygiene & Tropical Medicine
London, United Kingdom
ACTIVE_NOT_RECRUITINGNumber of Biological Samples Testing Positive for Treponema pallidum DNA by PCR
This outcome measures the presence of Treponema pallidum (Tp) DNA in collected biological samples-including lesion swabs, blood, urine, saliva, and oral/anal/genital swabs-using a validated T. pallidum polymerase chain reaction (Tp PCR) assay. Data will be reported as the number and proportion of samples that test positive, stratified by: * sample type, * clinical stage of syphilis, * anatomical site (where applicable), * and participant characteristics relevant to the SOS Global protocol. No scale is used; this is a binary laboratory outcome (PCR positive / PCR negative).
Time frame: Samples are taken at time of consent - single visit study
Load of Treponema pallidum DNA in Positive Biological Samples by In-house Quantitative PCR (qPCR) assay
This outcome measures the load (copies/mL) of Treponema pallidum (Tp) DNA in collected biological samples-including lesion swabs, blood, urine, saliva, and oral/anal/genital swabs-using an in-house validated quantitative T. pallidum polymerase chain reaction (Tp qPCR) assay. Data will be reported as a comparison in load between anatomical sites and by clinical stage of syphilis.
Time frame: Samples are taken at time of consent - single visit study
Number of Treponema pallidum-Positive Samples Demonstrating Viable Organisms via Novel In-house Viability Assay
This outcome measures the viability of detected Treponema pallidum in PCR-positive biological samples. Viability is assessed using a novel in-house viability assay. Results will be summarised as the number and proportion of Tp PCR-positive samples that contain viable organisms, stratified by sample type and clinical/epidemiological variables specified in the SOS Global protocol. This outcome focuses on confirming whether Tp organisms in collected specimens are capable of establishing infection, rather than merely detecting genetic material. The viability assessment does not result in a continuous scale; it is a binary laboratory outcome (viable / non-viable).
Time frame: Samples are collected at time of consent - single study visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.