Evidence map›Paper›PMID 32522244›Full record

ArticleBMC infectious diseases2020

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

Melanie M Taylor, Edna Oliveira Kara, Maria Alix Leite Araujo, Mariangela Freitas Silveira, Angelica Espinosa Miranda, Ivo Castelo Branco Coelho, Maria Luiza Bazzo, Gerson Fernando Mendes Pereira, Silvana Pereira Giozza, Ximena Pamela Díaz Bermudez and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03752112 (Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03752112 phase1 / phase2unknown statusnot on this map

Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women

TypeinterventionalSponsorWorld Health OrganizationRan2019 to 2021Enrolled180ConditionsSyphilis FemaleArmsCefixime, Benzathine penicillin 2.4 million units
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Review
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  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Public policies on sexually transmitted infections in Brazil.Revista da Sociedade Brasileira de Medicina Tropical · 2021
    Article
  12. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 3 countries.

Melanie M TaylorDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland. mtaylor@who.int.
Edna Oliveira KaraDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Maria Alix Leite AraujoUniversity of Fortaleza (UNIFOR), Fortaleza, Brazil.
Mariangela Freitas SilveiraPost-Graduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil.
Angelica Espinosa MirandaFederal University of Espírito Santo, Vitória, Brazil.
Ivo Castelo Branco CoelhoFederal University of Ceará, Ambulatório de IST do Hospital Universitário da Universidade Federal do Ceará, Fortaleza, Brazil.
Maria Luiza BazzoFederal University of Santa Catarina, Florianópolis, Brazil.
Gerson Fernando Mendes PereiraBrazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.
Silvana Pereira GiozzaBrazil Ministry of Health, Secretariat for Health Surveillance, Department of Chronic Conditions and Sexually Transmitted Infections, Brasília, Brazil.
Ximena Pamela Díaz BermudezUniversity of Brasília, Brasília, Brazil.
Maeve B MelloUniversity of Brasília, Brasília, Brazil.
Ndema HabibDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
My Huong NguyenDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Soe Soe ThwinDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Nathalie BroutetDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
World Health Organization · CHMinistério da Saúde · BRUniversidade de Brasília · BRUniversidade de Fortaleza · BRUniversidade Federal de Pelotas · BRUniversidade Federal de Santa Catarina · BRUniversidade Federal do Ceará · BRUniversidade Federal do Espírito Santo · BRWorld Health Organization Regional Office for the Americas · US

Funding

World Health Organization NA
6 · The paper itself

Abstract

backgroundSyphilis 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.

methodsThis 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 registrationTrial identifier: www.Clinicaltrials.gov, NCT03752112. Registration Date: November 22, 2018.

Indexed as

Anti-Bacterial AgentsBrazilCefiximeClinical Trial Protocols as TopicClinical Trials, Phase II as TopicFemaleHumansPenicillin G BenzathineRandom AllocationSyphilisTreatment OutcomeTreponema pallidumAnti-Bacterial AgentsCefiximePenicillin G BenzathineAlternative treatmentBenzathine penicillincefiximeCongenital syphilisSexually transmitted infectionsSyphilis

Identifiers

PMID32522244
PMCPMC7288542
OpenAlexW3033018126

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.