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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
trial testing No Intervention: Observational Cohort in Syphilis in 480 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Monash University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 480 |
| Start date | 2 December 2025 |
| Primary completion | 30 June 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 9 locations across China, South Africa, United Kingdom, Australia |
Drugs / interventions tested
- No Intervention: Observational Cohort — full drug profile →
Conditions studied
- Syphilis — all drugs for Syphilis →
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.
Verify or expand the search:
- PubMed search for NCT07300254
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07300254 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Monash University
- Last refreshed: 3 April 2026
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