دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra).
المؤلفون: Taylor MM; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland. mtaylor@who.int.; U.S. Centers for Disease Control and Prevention, Division of STD Prevention, Atlanta, GA, USA. mtaylor@who.int., Kara EO; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Araujo MAL; University of Fortaleza (UNIFOR), Fortaleza, Brazil., Silveira MF; Post-Graduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil., Miranda AE; Federal University of Espírito Santo, Vitória, Brazil., Branco Coelho IC; Federal University of Ceará, Ambulatório de IST do Hospital Universitário da Universidade Federal do Ceará, Fortaleza, Brazil., Bazzo ML; Federal University of Santa Catarina, Florianópolis, Brazil., Mendes Pereira GF; Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil., Pereira Giozza S; Brazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil., Bermudez XPD; University of Brasília, Brasília, Brazil., Mello MB; University of Brasília, Brasília, Brazil.; Department of Communicable Diseases and Environmental Determinants of Health, Pan American Health Organization/World Health Organization, Washington, Washington, DC, USA., Habib N; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Nguyen MH; Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., 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.
المصدر: BMC infectious diseases [BMC Infect Dis] 2020 Jun 10; Vol. 20 (1), pp. 405. Date of Electronic Publication: 2020 Jun 10.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001-
مواضيع طبية MeSH: Anti-Bacterial Agents/*therapeutic use , Cefixime/*therapeutic use , Syphilis/*drug therapy, Brazil/epidemiology ; Clinical Trial Protocols as Topic ; Clinical Trials, Phase II as Topic ; Female ; Humans ; Penicillin G Benzathine/therapeutic use ; Random Allocation ; Syphilis/microbiology ; Syphilis/prevention & control ; Treatment Outcome ; Treponema pallidum/drug effects ; Treponema pallidum/isolation & purification
مستخلص: 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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معلومات مُعتمدة: NA International World Health Organization
فهرسة مساهمة: Keywords: Alternative treatment; Benzathine penicillin; Congenital syphilis; Sexually transmitted infections; Syphilis; cefixime
سلسلة جزيئية: ClinicalTrials.gov NCT03752112
المشرفين على المادة: 0 (Anti-Bacterial Agents)
97I1C92E55 (Cefixime)
RIT82F58GK (Penicillin G Benzathine)
تواريخ الأحداث: Date Created: 20200612 Date Completed: 20200720 Latest Revision: 20231111
رمز التحديث: 20231111
مُعرف محوري في PubMed: PMC7288542
DOI: 10.1186/s12879-020-04980-1
PMID: 32522244
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-2334
DOI:10.1186/s12879-020-04980-1