Dataset Information

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

ABSTRACT: 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.

SUBMITTER: Taylor MM

PROVIDER: S-EPMC7288542 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Taylor Melanie M MM Kara Edna Oliveira EO Araujo Maria Alix Leite MAL Silveira Mariangela Freitas MF Miranda Angelica Espinosa AE Branco Coelho Ivo Castelo IC Bazzo Maria Luiza ML Mendes Pereira Gerson Fernando GF Pereira Giozza Silvana S Bermudez Ximena Pamela Díaz XPD Mello Maeve B MB Habib Ndema N Nguyen My Huong MH Thwin Soe Soe SS Broutet Nathalie N

BMC infectious diseases 20200610 1

<h4>Background</h4>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 urge ...[more]

PMID: 32522244

Similar Datasets

Project description:BackgroundUntreated male partners are a critical source of maternal re-infection. Contact tracing is a good way to identify infection among partners and reduce risk of mother-to-child transmission related to maternal re-infection. This study aimed to analyze the current situation and related factors of contact tracing of syphilis-seropositive pregnant women and syphilis-infection among their male partners.MethodData of syphilis-seropositive pregnant women and their male partners attending clinic for syphilis-screening were obtained from the Shenzhen Program for Prevention of Congenital Syphilis. Contact tracing rate of syphilis-seropositive pregnant women and syphilis prevalence among male partners were counted, and related factors were also analyzed using a random-effects logistic regression model.ResultOf the 1299 syphilis-seropositive pregnant women, 74.1% (963/1299) had their male partners receiving syphilis-screening and 19.1% (184/963) of male partners were syphilis-infected. For pregnant women, being divorced (adjusted odds ratio [AOR] =0.39; 95%CI: 0.17-0.87), seeking for emergency services at their first antenatal clinics visits (AOR = 0.58; 95%CI: 0.44-0.77), reporting willingness to notify partner(AOR = 7.65; 95%CI: 4.69-12.49), multi-partners (AOR = 1.38; 95%CI:1.03-1.86) and having a history of drug abuse (AOR = 0.37; 95%CI: 0.14-1.00)were independently associated with successful contact tracing. For male partners, of minority ethnicity (AOR = 4.15; 95%CI: 1.66-10.34), age at first sex>20(AOR = 0.57; 95%CI: 0.37-0.87), reporting multi-partners (AOR = 1.60; 95%CI: 1.04-2.46), having a history of drug abuse (AOR = 4.07; 95%CI: 1.31-12.64) were independently associated with syphilis-infection. In addition, pregnant women with TRUST titer ≥1:8 (AOR = 2.81; 95%CI: 1.87-4.21), having a history of adverse pregnancy outcomes (AOR = 1.70; 95%CI: 1.14-2.53), reporting multi-partners (AOR = 0.43; 95%CI: 0.29-0.64) and reporting the current partner as the source of syphilis (AOR = 5.05; 95%CI: 2.82-9.03) were independently associated with partners' syphilis-infection.ConclusionContact tracing is feasible and effective in identifying syphilis-infected partners among syphilis-seropositive pregnant women. Contact tracing is associated with many factors such as women's marital status, services at their first antenatal clinics visit and willingness of partner notification. Partners' ethnicity, age at first sex, multi-partners and history of drug abuse as well as women's levels of TRUST titer were associated with partners' syphilis-infection.

Project description:ObjectiveSyphilis is one of the most imperative STIs, caused by the spirochete Treponema pallidum. During pregnancy it is associated with disastrous health outcomes in the newborn. In sub-Saharan Africa, study findings on the prevalence of syphilis among pregnant women are highly dispersed and inconsistent. The aim of the current review is to conduct a systematic review and meta-analysis of syphilis in sub-Saharan Africa among pregnant women.DesignSystematic review and meta-analysis.Data sourcesDatabases including MEDLINE, PubMed, Cochrane Library, Google Scholar, and HINARI and reference lists of previous prevalence studies were systematically searched for relevant literature from January 1999 to November 2018. Results were presented in forest plot, tables, and figures. Random-effects model was used for the meta-analysis. For the purpose of this review, a case of syphilis was defined as positive treponemal or nontreponemal tests among pregnant women.Data extractionOur search gave a total of 262 citations from all searched databases. Of these, 44 studies fulfilling the inclusion criteria and comprising 175,546 subjects were finally included.ResultsThe pooled prevalence of syphilis among pregnant women in sub-Saharan Africa was 2.9% (95%CI: 2.4%-3.4%). East and Southern African regions had a higher syphilis prevalence among pregnant women (3.2%, 95% CI: 2.3%-4.2% and 3.6%, 95%CI: 2.0%-5.1%, respectively) than the sub-Saharan African pooled prevalence. The prevalence of syphilis among pregnant women in most parts of the region seemed to have decreased over the past 20 years except for the East African region. However, prevalence did not significantly differ by region and time period.ConclusionThis review showed a high prevalence of syphilis in sub-Saharan Africa among pregnant women. The evidence suggests strengthening the screening program during pregnancy as part of the care package during antenatal care visits. Programs focusing on primary prevention of syphilis in women should also be strengthened.

Dataset Information

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

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets