NCT07189208 Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
| NCT ID | NCT07189208 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, Los Angeles |
| Condition | Congenital Syphilis |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 500 participants in total. It began in 2025-09-24 with a primary completion date of 2029-12-01.
⚠ 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
The goal of this clinical trial is to learn if benzathine penicillin works to prevent maternal syphilis. It will also learn about the safety of benzathine penicillin. The main questions it aims to answer are: * Does benzathine penicillin lower the rate of syphilis in pregnancy? * What medical problems do participants have when taking benzathine penicillin? Researchers will compare benzathine penicillin to routine care to see if benzathine penicillin works to prevent syphilis. Participants will: * Take benzathine penicillin or receive routine care during the third trimester of pregnancy * Visit the clinic once a month for injections and tests * Report any reactions to benzathine penicillin to the study team
Eligibility Criteria
Inclusion Criteria: 1. Uncomplicated, viable pregnancy 2. Elevated risk for syphilis acquisition (one or more of the following): 1. Prior history of STIs last 3 years 2. HIV infection 3. Age \< 21 years 4. In a sexual partnership of \< 3 mo., or \> 3 sexual partners in the last 6 mo. 5. Late initiation of prenatal care (\> 14 weeks of pregnancy) 6. Residence in area where syphilis prevalence is 10% or higher. 3. Ability to provide written informed consent 4. No allergy to penicillin 5. Prenatal care at one of the sites participating in the study 6. Ongoing sexual activity during study period. 7. Negative rapid treponemal test at baseline. Exclusion Criteria: 1. Non-viable pregnancy 2. Very high risk pregnancy 3. Inability to provide written informed consent 4. Allergy to penicillin 5. Positive rapid treponemal test at baseline 6. Lack of sexual activity during study period. 7. Any persisting coagulation disorder that would contraindicate IM injections.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07189208 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Congenital Syphilis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07189208 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07189208 currently recruiting?
Yes, NCT07189208 is actively recruiting participants. Contact the research team at knielsen@mednet.ucla.edu for enrollment information.
Where is the NCT07189208 trial being conducted?
This trial is being conducted at Duque de Caxias, Brazil, Duque de Caxias, Brazil, Duque de Caxias, Brazil, Rio de Janeiro, Brazil.
Who is sponsoring the NCT07189208 clinical trial?
NCT07189208 is sponsored by University of California, Los Angeles. The trial plans to enroll 500 participants.