Comparing an oral antibiotic (cefixime) to penicillin shots for early syphilis
Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
This trial compares taking cefixime pills versus receiving penicillin injections to treat early syphilis in people with and without HIV.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Southern California NIH-funded |
| Lab location | 1 site (Los Angeles, UNITED STATES) |
| Project ID | NIH-11159118 on NIH RePORTER |
What this research studies
If you join, you will be randomly assigned to take cefixime pills twice a day for 10 days or receive a single benzathine penicillin G injection. The study will enroll 360 people with early syphilis across nine U.S. clinical sites and includes participants with and without HIV. Doctors will monitor symptoms and blood tests (RPR titers) every three months for nine months to see whether the infection clears. The trial is open-label, so you and your care team will know which treatment you receive, and it is designed to show whether cefixime works at least as well as penicillin.
Who could benefit from this research
Good fit: Adults with early syphilis, including people living with HIV, who can attend regular follow-up visits and take oral medication or receive injections.
Not a fit: Pregnant people, those with late-stage or neurosyphilis, or anyone unable to take the study medications or attend follow-up visits may not be eligible or receive benefit.
Why it matters
Potential benefit: If successful, this could offer an effective oral alternative to penicillin injections, making treatment easier to access and use for many patients.
How similar studies have performed: A prior pilot study suggested cefixime may be effective, but few large randomized trials have tested oral alternatives to penicillin for syphilis.
Where this research is happening
Los Angeles, UNITED STATES
- University of Southern California — Los Angeles, United States (Active)
Researchers
- Principal investigator: Klausner, Jeffrey David — University of Southern California
- Study coordinator: Klausner, Jeffrey David
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 below.