NCT07300254 Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission
| NCT ID | NCT07300254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Monash University |
| Condition | Syphilis |
| Study Type | OBSERVATIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 480 participants in total. It began in 2025-12-02 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: \- 1. Any cis-woman, cis-MSW, or nonbinary individuals with a penis who have sex with women only, (who meet all other study criteria) 2. Aged ≥18 years of age, 3. At least one sexual partner in the last 12 months 4. One of either: a. Untreated clinically suspected primary or secondary syphilis. i. Must have rash or lesion(s) clinically suggestive of early infectious syphilis infection. ii. May have positive PCR result, positive Dark-ground Microscopy result, positive syphilis serology or positive point-of-care syphilis test, but these are not necessary at the time of enrolment. b. Untreated early latent (no clinical signs indicative of primary or secondary syphilis) syphilis with positive syphilis serology or positive point-of-care test, and one or more of the following(11): i. A documented syphilis seroconversion within the prior 12 months. ii. A sustained (longer than 2 weeks) fourfold or greater increase in the titre in the prior 12 months in a person previously treated for syphilis. iii. Unequivocal symptoms of primary or secondary syphilis within the prior 12 months. iv. Contact in the prior 12 months with a sex partner who had untreated primary, secondary, or early latent syphilis. v. Documented reactive nontreponemal and treponemal tests, and the only possible exposure occurred during the previous 12 months vi. RPR/VDRL titre \>= 1:64 5. Be willing and able to complete study procedures, including physical examination 6. Receiving syphilis treatment on the day of recruitment 7. Have sufficient language proficiency to understand the requirements of the study 8. Provide informed consent as per individual site's local ethics requirements Exclusion Criteria: 1. Men, transwomen, or other people, with a penis, who have had any sexual contact, including kissing, oral sex or anal sex, with men (or any other individual with a penis) in the previous one year. 2. Individuals who have received antibiotic treatment within 1 month prior to enrolment, with the EXCEPTION of metronidazole. 3. Diagnosis of late latent syphilis (\>1 year) or latent syphilis of unknown duration.
Contact & Investigator
Janet Towns
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT07300254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Syphilis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07300254 currently recruiting?
Yes, NCT07300254 is actively recruiting participants. Contact the research team at brigid.scally@monash.edu for enrollment information.
Where is the NCT07300254 trial being conducted?
This trial is being conducted at Melbourne, Australia, Shanghai, China, Shanghai, China, Johannesburg, South Africa and 5 additional locations.
Who is sponsoring the NCT07300254 clinical trial?
NCT07300254 is sponsored by Monash University. The principal investigator is Janet Towns at Monash University. The trial plans to enroll 480 participants.