Congenital Syphilis: Amoxicillin vs Penicillin for Newborns
Official title: Congenital Syphilis Treatment Trial (CONSISTENT): Phase IV, Open-label, Randomized Controlled Trial of Amoxicillin vs Benzathine Penicillin in Neonates with Possible Congenital Syphilis
Funded at University of Alabama at Birmingham · NIH-11258325 · Data updated 2026-11-12
A new trial will compare an oral antibiotic (amoxicillin) with the standard shot (benzathine penicillin) for babies with possible congenital syphilis to see which works better.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Alabama at Birmingham NIH-funded |
| Lab location | 1 site (Birmingham, United States) |
| Project start | May 12, 2026 |
| Project end | April 30, 2031 |
| Funding year | 2026 |
| Award (this year) | $2,336,069 |
| NIH project number | 1U01AI195199-01 |
| Project ID | NIH-11258325 on NIH RePORTER |
Who could benefit from this research
✓Could help
Infants ≥35 weeks gestation with possible congenital syphilis (exposed but with negative initial syphilis evaluation) and whose guardians consent to participate.
✕Less likely to help
Infants who do not meet eligibility or who do not respond serologically may not receive a direct benefit from participation.
What this research studies
This study tests whether giving amoxicillin by mouth for 10 days is as effective as the usual single injection of benzathine penicillin in newborns with possible congenital syphilis. It is a phase IV, open-label randomized trial across 12 US sites, enrolling up to 374 neonates aged 0 to 4 weeks. Participants may also join an optional pharmacokinetic substudy and will contribute nasal/oral swabs for PCR testing to understand infection dynamics. The goal is to compare serologic responses within 6 months to determine if oral therapy can be a reliable alternative when injections are difficult to obtain. Results could influence treatment guidelines and improve access to therapy for affected infants.
Why it matters
Potential benefit: If amoxicillin proves as effective, more flexible and accessible treatment options could reduce delays and shortages in care for newborns with possible congenital syphilis.
How similar studies have gone: This is one of the first large randomized comparisons of amoxicillin versus benzathine penicillin in this specific newborn population, with prior evidence suggesting potential non-inferiority in related settings but not definitive for CS.
Where this research is happening
-
University of Alabama at Birmingham
Birmingham, United States Active
Researchers
- Principal investigator: Kimberlin, David W. — University of Alabama at Birmingham
- Study coordinator: Kimberlin, David W.
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.