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New hope for newborns: simpler syphilis treatment on trial

NCT ID NCT07457385

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests whether a 10-day course of oral amoxicillin works as well as a single injected dose of penicillin to treat congenital syphilis in newborns up to 30 days old. About 374 infants across 12 U.S. sites will be randomly assigned to one of the two treatments. The goal is to find a simpler, effective option that may be easier for families to manage at home.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 374 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

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

0 to 30 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Confirmed staged maternal syphilis in pregnancy with rapid plasma reagin (RPR) + and T. pallidum hemagglutination antibody (TPHA) or other evidence of active syphilis (i.e. ulcerative anogenital lesion with positive darkfield microscopy or PCR+ for T. pallidum) 2. Inadequate therapy (non-BPG regimen, incomplete regimen for stage, \<30 days prior to delivery), undocumented therapy, or lack of maternal syphilis therapy in pregnancy 3. Infant age ≤ 30 days old 4. Gestational age at birth ≥35 weeks 5. Infant birth weight ≥ 750 grams 6. Infant tolerating oral feeds 7. Normal infant examination, laboratory, and radiographic evaluation: hemoglobin, platelet count, CSF (cell count, protein, VDRL), long-bone radiographs 8. Infant quantitative RPR reactive and ≤ 4-fold lower titer compared with maternal RPR 9. Parent(s) or legal guardian(s) capable and willing to provide informed consent Exclusion Criteria: 1. Infant receipt of antibiotics between birth and enrollment with activity against T. pallidum (including beta-lactam, cephalosporin, or azithromycin) 2. Uncontrolled maternal HIV (viral load \>1000 copies/mL at or within 4 weeks of delivery) or HIV-exposed infants who require three drug antiretroviral post exposure prophylaxis. 3. Unable to ensure infant follow up through six months of age

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Conditions

The condition(s) this trial relates to.

congenital syphilis

As listed by the trial registrant

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

Syphilis, congenital

How to take part

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

  1. The places running it

    11 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

  • Avera McKennan University Health Center

    Sioux Falls, South Dakota, 57105, United States

  • Baylor College of Medicine-Texas Children's Hospital

    Houston, Texas, 77030, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • LSU Health Sciences Center-Shrevport

    Shreveport, Louisiana, 71103, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87106, United States

  • University of South Alabama Medical Center

    Mobile, Alabama, 36617, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Texas-Southwestern Medical Center at Dallas

    Dallas, Texas, 75390, United States

  • Washington University-St.Louis

    St Louis, Missouri, 63310, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.