Infectious Disease

Twice-daily oral cefixime that is nearly 90% successful in treating early syphilis

March 14, 2021

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Orally administered cefixime given orally twice daily for 10 days was nearly 90% successful in treating early syphilis, according to a study published in Clinical Infectious Diseases.

Jeffrey Klausner, MD, MPH, The University of Southern California’s Keck School of Medicine clinical professor of preventive medicine and colleagues noted that both the CDC and WHO recommend injectable benzathine penicillin G for syphilis – and that doxycycline is the only recommended treatment for syphilis during pregnancy . Tetracycline and ceftriaxone are recommended as alternatives with reservations.

Syphilis Infographic

Source: Stafylis C, et al. Clin Infect Dis. 202; doi: 10.1093 / cid / ciab187.

“While the recommended treatment for early syphilis is injectable penicillin, in many places penicillin is not available. In the US, injectable penicillin can cost $ 350 or more for a single shot, and while it is cheaper in many parts of the world, it is simply not available due to very limited manufacturing, ”Klausner told Healio. “The syphilis is increasing. The United States had the highest rate of congenital syphilis in more than 25 years. There is an urgent public health need for more treatments for syphilis. Treatments that are safe, inexpensive, and readily available are the most important. “

Between September 2018 and January 2020, Klausner and colleagues conducted a randomized, open, non-comparative pilot study in men and women diagnosed with primary, secondary, or early latent syphilis.The participants were randomly given 1: 1 either intrathuscular benzathine penicillin G 2.4 MIU 400 mg oral cefixime once or 10 days twice daily.

Jeffrey Klausner

“Cefixime is an FDA-approved third generation orally administered cephalosporin,” wrote Klausner and colleagues, “and cephalosporins may be good candidates for evaluation” for the treatment of early syphilis.

According to the study, 58 participants were enrolled 27 in the cefixime arm and 31 in the penicillin arm. All randomly assigned participants were included in the intent-to-treat population, while the pro-protocol population included 15 participants randomly assigned to the cefixime arm and 15 randomly assigned to the penicillin arm.

In the per-protocol population analysis, response to treatment at 3 or 6 months was 93% (95% CI, 81% -100%) of participants in the penicillin arm and 87% (95% CI, 69% -100%) of participants in the penicillin arm, and 87% (95% CI, 69% -100 %) reached. ) in the cefixime arm, while in the intent-to-treat analysis the response to treatment was 81% (95% CI, 67% -95%) in the penicillin arm and 56% (95% CI, 37% – 74) was achieved%) in the cefixime arm.

According to the study, three cases of serological failure were recorded – two of them

Participants in the cefixime arm and one in a participant in the penicillin arm. In addition, one adverse event was recorded from the 27 participants who received cefixime. The study detailed that within 4 hours of receiving the first dose of cefixime, the participant reported a mild rash and was advised to discontinue treatment and was reassessed at the clinic.

“The takeaway message is that cefixime shows promise but more research and larger study is needed,” said Klausner. “To address the antibiotic development crisis, we can and should work to use older, safer drugs as new treatments.”

Klausner said the researchers began working on a larger randomized controlled trial in the US and Peru to see if cefixime and injectable penicillin were working, and they expanded the study population to include women.

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