Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra)

BMC Infectious Diseases
Melanie M TaylorNathalie Broutet

Abstract

Syphilis is a sexually and vertically transmitted infection caused by the bacteria Treponema pallidum for which there are few proven alternatives to penicillin for treatment. For pregnant women infected with syphilis, penicillin is the only WHO-recommended treatment that will treat the mother and cross the placenta to treat the unborn infant and prevent congenital syphilis. Recent shortages, national level stockouts as well as other barriers to penicillin use call for the urgent identification of alternative therapies to treat pregnant women infected with syphilis. This prospective, randomized, non-comparative trial will enroll non-pregnant women aged 18 years and older with active syphilis, defined as a positive rapid treponemal and a positive non-treponemal RPR test with titer ≥1:16. Women will be a, domized in a 2:1 ratio to receive the oral third generation cephalosporin cefixime at a dose of 400 mg two times per day for 10 days (n = 140) or benzathine penicillin G 2.4 million units intramuscularly based on the stage of syphilis infection (n = 70). RPR titers will be collected at enrolment, and at three, six, and nine months following treatment. Participants experiencing a 4-fold (2 titer) decline by 6 months will be consid...Continue Reading

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Citations

Dec 19, 2020·Current Opinion in Obstetrics & Gynecology·Zi-Qi LiewCourtney Olson-Chen
Mar 18, 2021·Epidemiologia E Serviços De Saúde : Revista Do Sistema Unico De Saúde Do Brasil·Angélica Espinosa MirandaGerson Fernando Mendes Pereira
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May 20, 2021·Revista Da Sociedade Brasileira De Medicina Tropical·Angélica Espinosa MirandaGerson Fernando Mendes Pereira

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Methods Mentioned

BETA
serum collection
blood draw
contraception

Software Mentioned

Open Clinica Enterprise platform
SAS
Statistical Analysis System ( SAS )

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