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Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil

Study acronym: PRESERvE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 31, 2030 to Dec 1, 2029
    • Study completion date: Jan 31, 2030 to Jul 31, 2030
    • Start date: Nov 1, 2025 to Sep 24, 2025
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07189208
Lead Sponsor University of California, Los Angeles
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Congenital Syphilis
Related terms Syphilis, Congenital
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov