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Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra).
Taylor, Melanie M; Kara, Edna Oliveira; Araujo, Maria Alix Leite; Silveira, Mariangela Freitas; Miranda, Angelica Espinosa; Branco Coelho, Ivo Castelo; Bazzo, Maria Luiza; Mendes Pereira, Gerson Fernando; Pereira Giozza, Silvana; Bermudez, Ximena Pamela Díaz; Mello, Maeve B; Habib, Ndema; Nguyen, My Huong; Thwin, Soe Soe; Broutet, Nathalie.
Afiliación
  • Taylor MM; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland. mtaylor@who.int.
  • Kara EO; U.S. Centers for Disease Control and Prevention, Division of STD Prevention, Atlanta, GA, USA. mtaylor@who.int.
  • Araujo MAL; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
  • Silveira MF; University of Fortaleza (UNIFOR), Fortaleza, Brazil.
  • Miranda AE; Post-Graduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.
  • Branco Coelho IC; Federal University of Espírito Santo, Vitória, Brazil.
  • Bazzo ML; Federal University of Ceará, Ambulatório de IST do Hospital Universitário da Universidade Federal do Ceará, Fortaleza, Brazil.
  • Mendes Pereira GF; Federal University of Santa Catarina, Florianópolis, Brazil.
  • Pereira Giozza S; Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.
  • Bermudez XPD; Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.
  • Mello MB; University of Brasília, Brasília, Brazil.
  • Habib N; University of Brasília, Brasília, Brazil.
  • Nguyen MH; Department of Communicable Diseases and Environmental Determinants of Health, Pan American Health Organization/World Health Organization, Washington, Washington, DC, USA.
  • Thwin SS; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
  • Broutet N; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
BMC Infect Dis ; 20(1): 405, 2020 Jun 10.
Article en En | MEDLINE | ID: mdl-32522244
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sífilis / Cefixima / Antibacterianos Tipo de estudio: Clinical_trials Límite: Female / Humans País/Región como asunto: America do sul / Brasil Idioma: En Revista: BMC Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS Año: 2020 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sífilis / Cefixima / Antibacterianos Tipo de estudio: Clinical_trials Límite: Female / Humans País/Región como asunto: America do sul / Brasil Idioma: En Revista: BMC Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS Año: 2020 Tipo del documento: Article País de afiliación: Suiza Pais de publicación: Reino Unido