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BMC Infect Dis ; 20(1): 405, 2020 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-32522244

RESUMO

BACKGROUND: 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. METHODS: 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 considered as having an adequate or curative treatment response. DISCUSSION: Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis. TRIAL REGISTRATION: Trial identifier: www.Clinicaltrials.gov, NCT03752112. Registration Date: November 22, 2018.


Assuntos
Antibacterianos/uso terapêutico , Cefixima/uso terapêutico , Sífilis/tratamento farmacológico , Brasil/epidemiologia , Protocolos de Ensaio Clínico como Assunto , Ensaios Clínicos Fase II como Assunto , Feminino , Humanos , Penicilina G Benzatina/uso terapêutico , Distribuição Aleatória , Sífilis/microbiologia , Sífilis/prevenção & controle , Resultado do Tratamento , Treponema pallidum/efeitos dos fármacos , Treponema pallidum/isolamento & purificação
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