Status:
RECRUITING
Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Congenital Syphilis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 ans...
Detailed Description
Syphilis rates during pregnancy have been rising consistently in Brazil in the last decade, with a parallel increase in the rates of congenital syphilis. The state of Rio de Janeiro, in particular, ha...
Eligibility Criteria
Inclusion
- Uncomplicated, viable pregnancy
- Elevated risk for syphilis acquisition (one or more of the following):
- Prior history of STIs last 3 years
- HIV infection
- Age \< 21 years
- In a sexual partnership of \< 3 mo., or \> 3 sexual partners in the last 6 mo.
- Late initiation of prenatal care (\> 14 weeks of pregnancy)
- Residence in area where syphilis prevalence is 10% or higher.
- Ability to provide written informed consent
- No allergy to penicillin
- Prenatal care at one of the sites participating in the study
- Ongoing sexual activity during study period.
- Negative rapid treponemal test at baseline.
Exclusion
- Non-viable pregnancy
- Very high risk pregnancy
- Inability to provide written informed consent
- Allergy to penicillin
- Positive rapid treponemal test at baseline
- Lack of sexual activity during study period.
- Any persisting coagulation disorder that would contraindicate IM injections.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07189208
Start Date
November 1 2025
End Date
January 31 2030
Last Update
November 18 2025
Active Locations (4)
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1
Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)
Duque de Caxias, Rio de Janeiro, Brazil
2
Policlínica Hospital Municipal Duque de Caxias
Duque de Caxias, Rio de Janeiro, Brazil
3
Unidade Básica de Saúde José de Freitas
Duque de Caxias, Rio de Janeiro, Brazil
4
Hospital Federal dos Servidores do Estado
Rio de Janeiro, Rio de Janeiro, Brazil