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NCT07300254: SOS Global

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

Recruiting now Last updated 3 April 2026
What this trial tests

trial testing No Intervention: Observational Cohort in Syphilis in 480 participants. Currently enrolling.

Timeline
2 December 2025
Primary endpoint
30 June 2027
31 December 2028

Quick facts

Lead sponsorMonash University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment480
Start date2 December 2025
Primary completion30 June 2027
Estimated completion31 December 2028
Sites9 locations across China, South Africa, United Kingdom, Australia

Drugs / interventions tested

Conditions studied

Sponsor

Monash University

Who can join

18 and older, any sex, with Syphilis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of No Intervention: Observational Cohort

Trials testing the same drug.

Other recruiting trials for Syphilis

Currently open trials in the same condition.

Other Monash University trials

Trials by the same sponsor.

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Data sources for this page

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