What side effects are associated with this type of intervention?

The most common treatments for syphilis, such as benzathine penicillin G, can cause side effects including allergic reactions (ranging from mild rashes to severe anaphylaxis) and gastrointestinal issues (nausea, vomiting, diarrhea). Cefixime, another antibiotic that inhibits bacterial cell wall synthesis, may cause gastrointestinal disturbances, hypersensitivity reactions, and occasionally hematologic issues like thrombocytopenia.

What prior FDA approvals exist?

The primary FDA-approved treatment for syphilis has been penicillin, specifically benzathine penicillin G, which is highly effective in all stages of the disease. Cefixime, a third-generation cephalosporin, is being studied for its efficacy in treating syphilis due to its mechanism of inhibiting bacterial cell wall synthesis, similar to penicillin. Other cephalosporins like ceftriaxone have also been used off-label for syphilis treatment, particularly in patients allergic to penicillin.

What other types of research exist?

Promising novel alternatives to Cefixime for the treatment of syphilis include benzathine penicillin G, which remains the gold standard. For patients allergic to penicillin, doxycycline and azithromycin are potential alternatives. Additionally, newer cephalosporins like ceftriaxone have shown efficacy in treating syphilis. Ongoing research into novel antibiotics and combination therapies may provide further options in the near future.

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Penicillin Antibiotic

Cefixime vs. Penicillin for Syphilis

Q: What is the mechanism of action of this treatment?

The most common treatments for Syphilis, such as benzathine penicillin G and cefixime, work by inhibiting bacterial cell wall synthesis. This mechanism is crucial because it prevents the bacteria from forming a protective cell wall, leading to cell lysis and death. For Syphilis patients, this means that the infection can be effectively eradicated, reducing symptoms and preventing complications. Benzathine penicillin G remains the gold standard due to its proven efficacy, but cefixime, which also inhibits cell wall synthesis, is being studied as a potential alternative, especially for patients who may have penicillin allergies.

Phase 3

Recruiting

Led By Jeffrey D Klausner, MD MPH

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment

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

Must not have

Patients showing signs and symptoms of neurosyphilis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares two antibiotics, cefixime taken by mouth and benzathine penicillin G given as an injection, to treat early syphilis. It includes patients with and without HIV to find an effective alternative to penicillin. The study aims to help those who are allergic to penicillin or affected by penicillin shortages. Cefixime is being tested as an alternative to penicillin for treating early syphilis, especially for those allergic to penicillin or during penicillin shortages.

Who is the study for?

This trial is for adults diagnosed with primary, secondary, or early latent syphilis who have an RPR titer of at least 1:8. People with HIV can join if they're on treatment and either have a low viral load or a CD4 count over 350. You can't join if you're pregnant, show signs of neurosyphilis, recently took certain antibiotics, are allergic to cephalosporins/penicillin, or can't make follow-up visits.

What is being tested?

The study compares the effectiveness of two treatments for syphilis: Cefixime (400mg) versus benzathine penicillin G. It aims to determine which medication works better in curing the infection.

What are the potential side effects?

Possible side effects may include allergic reactions like rashes or hives; gastrointestinal issues such as nausea or diarrhea; and less commonly, severe reactions like difficulty breathing due to anaphylaxis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with syphilis and my recent test shows a high level of infection.

Select...

I have HIV, am on treatment, and my viral load is under control or my CD4 count is above 350.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am showing signs of a brain or nerve condition caused by syphilis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response to treatment

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CefiximeExperimental Treatment1 Intervention

Oral cefixime 400mg, taken twice a day for 10 days

Group II: Benzathine Penicillin GActive Control1 Intervention

Single intramuscular injection of 2.4 million units of benzathine penicillin G

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Syphilis, such as benzathine penicillin G and cefixime, work by inhibiting bacterial cell wall synthesis. This mechanism is crucial because it prevents the bacteria from forming a protective cell wall, leading to cell lysis and death. For Syphilis patients, this means that the infection can be effectively eradicated, reducing symptoms and preventing complications. Benzathine penicillin G remains the gold standard due to its proven efficacy, but cefixime, which also inhibits cell wall synthesis, is being studied as a potential alternative, especially for patients who may have penicillin allergies.

In Vitro Synergy Testing of Gentamicin, an Old Drug Suggested as Future Treatment Option for Gonorrhoea, in Combination With Six Other Antimicrobials Against Multidrug-Resistant Neisseria gonorrhoeae Strains.