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Penicillin shots tested to stop syphilis in pregnancy

NCT ID NCT07189208

Prevention Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving penicillin shots to pregnant women at high risk for syphilis can prevent infection. Researchers in Rio de Janeiro will enroll 500 women and compare the shots to standard care. Participants receive monthly injections and tests during their third trimester.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
benzathine penicillin
What this could lead to
If it works, this could provide a simple way to prevent syphilis during pregnancy, reducing the risk of passing the infection to the baby.
What could go wrong
This is a Phase 2 trial, so it's still early. The drug may not prevent infection as hoped, and some participants may have allergic reactions or side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

congenital syphilis prevention target syphilis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital syphilis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)

    NOT_YET_RECRUITING

    Duque de Caxias, Rio de Janeiro, Brazil

  • Hospital Federal dos Servidores do Estado

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, Brazil

  • Policlínica Hospital Municipal Duque de Caxias

    RECRUITING

    Duque de Caxias, Rio de Janeiro, Brazil

  • Unidade Básica de Saúde José de Freitas

    NOT_YET_RECRUITING

    Duque de Caxias, Rio de Janeiro, Brazil