SyphilisPhase 3NCT04958122
Cefixime Clinical Trial
A Phase 3 study testing Cefixime 400mg and benzathine penicillin in people with Syphilis and Human Immunodeficiency Virus, run by University of Southern California at 1 site in United States.
Trial summary
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syphilis, Human Immunodeficiency Virus
- What is being tested?
- Cefixime 400mg and benzathine penicillin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2021to 30 Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
- 18 years of age or older
- Able to provide informed consent
- Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load <200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment
Who cannot join
- Pregnancy or a positive pregnancy test on the day of enrollment
- Patients showing signs and symptoms of neurosyphilis
- Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater
- Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin)
- Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test
- Self-reported allergy to cephalosporins or penicillin
- Unwilling or unable to attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90032
Jeffrey D Klausner, MD, (415) 876-8901, jdklausner@med.usc.edu
About this study
Official title: Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
Read the detailed description
This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.
- Conditions
- Syphilis, Human Immunodeficiency Virus
- Being tested
- Cefixime 400mg, benzathine penicillin
- Keywords
- Cefixime, Treponema pallidum, Penicillin, Early Syphilis
- Medical subject headings
- Syphilis, Acquired Immunodeficiency Syndrome, Treponemal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefixime 400mgDrug
Also called supprax
Oral cefixime 400 mg, one capsule, twice a day for 10 days
benzathine penicillinDrug
Also called bicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
| Study group | Role | What they receive |
|---|---|---|
| Cefixime | Experimental | Oral cefixime 400mg, taken twice a day for 10 days Receives: Drug: Cefixime 400mg |
| Benzathine Penicillin G | Active comparator | Single intramuscular injection of 2.4 million units of benzathine penicillin G Receives: Drug: benzathine penicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start20 Jun 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- AIDS Healthcare Foundation, Universidad Peruana Cayetano Heredia
- Responsible party
- Principal investigator, Jeffrey D Klausner, University of Southern California
- Investigators
- Jeffrey D Klausner, MD MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958122
- Sponsor's protocol ID
- HS-21-00288
- Status last verified
- Apr 2026
- First submitted
- 29 Jun 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers