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Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission

NCT07300254 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Syphilis

Interventions

OTHER

No Intervention: Observational Cohort

No intervention: Observational study

Sponsors & Collaborators

  • Melbourne Sexual Health Centre

    collaborator UNKNOWN

  • The Alfred

    collaborator OTHER

  • Monash University

    lead OTHER

Principal Investigators

  • Janet Towns · Monash University

  • Marcus Chen · Monash University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2027-06-30
Completion
2028-12-31

Countries

  • Australia
  • China
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300254 on ClinicalTrials.gov