RBR-8sv2kp Study on the use of Cefixime for the treatment of syphilis in Brazil

Date of registration: 04/26/2019 ^(mm/dd/yyyy)
Last approval date : 11/29/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1225-6121

• Public title:

  en

  Study on the use of Cefixime for the treatment of syphilis in Brazil

  pt-br

  Ensaio cl?nico avaliando a efic?cia da cefixima no tratamento da s?filis ativa em mulheres n?o gr?vidas no Brasil (CeBra)

• Scientific acronym:

  pt-br

  ERAPT

• Public acronym:

  pt-br

  ERAPT

• Secondaries identifiers:
  • 98496918.5.1001.5052
    Issuing authority: Plataforma Brasil
  • ERC.0003096
    Issuing authority: ERC WHO
  • CEP: 3.006.399
    Issuing authority: Comitê de Ética em Pesquisa da Universidade de Fortaleza (UNIFOR)/Fundação Edson Queiroz

Sponsors

• Primary sponsor: Universidade de Fortaleza
• Secondary sponsor:
  • Institution: Universidade de Fortaleza
• Supporting source:
  • Institution: Organização Mundial de Saúde
  • Institution: Ministério da Saúde

Health conditions

• Health conditions:

  en

  Syphilis

  pt-br

  Sifilis precoce/Ensaio Clinico

• General descriptors for health conditions:

  en

  A00-B99 I - Certain infectious and parasitic diseases

  pt-br

  A00-B99 I - Algumas doenças infecciosas e parasitárias

• Specific descriptors:

Interventions

• Interventions:

  en

  This is a phase 1/2 clinical trial to assess the efficacy and safety of Cefixima for use in the treatment of women with early syphilis. This is a randomized, non-comparative and open study that assesses the efficacy and safety of Cefixima 400mg ingested twice a day for 10 consecutive days in non-pregnant women with early syphilis. To evaluate the performance of benzathine penicillin in the study population that is being used for Cefixima, we will include a contemporary group of participants who receive standard treatment of benzathine penicillin treatment according to the Brazilian guidelines for the treatment of sexually transmitted infections (STI). We will use a proportion of 2 patients receiving the antibiotic Cefixime for 1 patient receiving penicillin. In total 120 women will be part of the intervention group and will receive Cefixima 400 mg twice daily for 10 days. Sixty women will be part of the contemporaneous group and receive 2.4 million of benzathine penicillin units (1.2 million units in each gluteus) once, according to national guidelines.

  pt-br

  Sifilis precoce/Ensaio Clinico

• Descriptors:

  en

  E02.319 Drug Therapy

  pt-br

  E02.319 Tratamento Farmacológico

  es

  E02.319 Tratamiento Farmacológico

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 04/01/2019 ^(mm/dd/yyyy)
• Date last enrollment: 11/01/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  210	F	18 Y	65 Y

• Inclusion criteria:

  en

  Female, 18 years of age or older; non-pregnant; able to provide informed consent; test positive for syphilis with a positive TPPA and an RPR titer equal to or greater than 1:8; non-cephalosporin allergic; non-penicillin allergic; agree to be called once a day by study staff to be reminded to take study drug; able to swallow pills; willing to attend follow-up visits at 3, 6, and 9 months after completion of the study treatment; willing to take oral contraceptive or use condom to prevent pregnancy during the study period; HIV negative

  pt-br

  Mulheres n?o gr?vidas, capazes de fornecer o consentimento informado; Ter o teste de RPR reagente para s?filis com t?tulos iguais ou superiores a 1:16; N?o ser al?rgica a cefalosporina e a penicilina, concordar em receber telefonemas uma vez ao dia pela equipe do estudo lembrando-a de tomar o medicamento e aos trinta dias ap?s a tomada para avalia??o de seguran?a do medicamento; Conseguirem engolir os comprimidos; Estar disposta a comparecer ? unidade para seguimento com duas semanas, 3, 6 e 9 meses ap?s o t?rmino do tratamento; Aceitar tomar contraceptivo oral ou usar camisinha para prevenir a gravidez durante o per?odo do estudo; Teste negativo para HIV.

• Exclusion criteria:

  en

  Female under 18 years of age; HIV positive; pregnancy test positive or clinical pregnancy; prior history of syphilis or syphilis treatment within 6 months of study screening; allergy to penicillin or cephalosporins (including allergy to cefixime); in the judgment of the interviewer, has a medical condition or other factor that might affect their ability to follow the protocol; previous enrollment in the study; presenting a condition that would not allow reliable informed consent (alcohol abuse or substance misuse); lacking mental capacity to give informed consent to participation.

  pt-br

  Mulheres com idade inferior a 18 anos; HIV positivo; Teste de gravidez positivo ou diagn?stico cl?nico de gravidez; Hist?ria pr?via de s?filis ou tratamento para s?filis dentro de 6 meses ap?s a triagem do estudo, Al?rgicas ? penicilina ou cefalosporinas (incluindo alergia ? cefixima); No julgamento do entrevistador, ter alguma condi??o m?dica ou outro fator que possa afetar sua capacidade de seguir o protocolo; Ter sido inscrita previamente no estudo; Apresentar alguma condi??o que impe?a assinar o consentimento informado e confi?vel (abuso de ?lcool ou abuso de subst?ncias);Incapacidade mental para dar consentimento informado ? participa??o; pessoas que n?o permitirem o armazenamento por um ano das amostras de sangue para poss?veis rean?lises. Como ocorre com todos os pacientes diagnosticados e atendidos com s?filis nessas unidades, todos os indiv?duos ser?o solicitados a convocar todos os parceiros com os quais tiveram sexo anal, oral ou vagina.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	1-2

Outcomes

• Primary outcomes:

  en

  It is expected to detect a decrease of 4 titles in the RPR exam at 6 months after treatment when compared to the initial values. Women who present this decrease in title will be considered as having a positive response to treatment.

  pt-br

  Espera-se detectar uma diminuição de 4 títulos no exame de RPR aos 6 meses apos o tratamento quando comparados aos valores iniciais. Mulheres que apresentarem esta diminuição de título serão consideradas como tendo uma resposta positiva ao tratamento. `

• Secondary outcomes:

  en

  is expected to evaluate the safety and tolerability of Cefixima in the treatment of syphilis through the proportion of treated patients who present mild, moderate, severe or life-threatening adverse events, temporally or not associated with the medicine of Study. The common terminology criteria for adverse events (CTCAE) will be used to evaluate the side effects and their severity.

  pt-br

  Espera-se avaliar a segurança e tolerabilidade da Cefixima no tratamento da sífilis atraves da proporção de pacientes tratadas que apresentarem eventos adversos leves, moderados, graves ou com risco de vida, associados temporalmente ou não ao medicamento do estudo. Serão utilizados os Critérios de Terminologia Comum para Eventos Adversos (CTCAE) para avaliar os efeitos colaterais e a gravidade dos mesmos.

Contacts

• Public contact
  • Full name: Maria Alix Leite Araujo
  • • Address: Av. Washington Soares, 1321. Bairro Edson Queiroz
    • City: FORTALEZA / Brazil
    • Zip code: 60811-905
  • Phone: +55-85 999843349
  • Email: alix.araujo@hotmail.com
  • Affiliation: Universidade de Fortaleza
   
• Scientific contact
  • Full name: Maria Alix Leite Araujo
  • • Address: Av. Washington Soares, 1321. Bairro Edson Queiroz
    • City: FORTALEZA / Brazil
    • Zip code: 60811-905
  • Phone: +55-85 999843349
  • Email: alix.araujo@hotmail.com
  • Affiliation: Universidade de Fortaleza
  • Full name: Maria Alix Leite Araujo
  • • Address: Av. Washington Soares, 1321. Bairro Edson Queiroz
    • City: FORTALEZA / Brazil
    • Zip code: 60811-905
  • Phone: +55-85 9999843349
  • Email: alix.araujo@hotmail.com
  • Affiliation: Universidade de Fortaleza
  • Full name: Maria Alix Leite Araujo
  • • Address: Av. Washington Soares, 1321. Bairro Edson Queiroz
    • City: FORTALEZA / Brazil
    • Zip code: 60811-905
  • Phone: +55-85 999843349
  • Email: alix.araujo@hotmail.com
  • Affiliation: Universidade de Fortaleza
   
• Site contact
  • Full name: Angelica Espinosa Miranda
  • • Address: Av. Fernando Ferrari, 514 - Goiabeiras
    • City: Vitória / Brazil
    • Zip code: 29075-910
  • Phone: +55-27 4009-2222
  • Email: angelica.miranda@ufes.br
  • Affiliation: Universidade Federal do Espirito Santo
  • Full name: Ivo Castelo Branco Coelho
  • • Address: Rua Alexandre Baraúna, 949 - Rodolfo Teófilo
    • City: FORTALEZA / Brazil
    • Zip code: 60430-160
  • Phone: +55-85 3366 8061
  • Email: ivo@ufc.br
  • Affiliation: Universidade Federal do Ceará
  • Full name: Maria Alix Leite Araujo
  • • Address: Av. Washington Soares, 1321. Bairro Edson Queiroz
    • City: FORTALEZA / Brazil
    • Zip code: 60811-905
  • Phone: +55-85 999843349
  • Email: alix.araujo@hotmail.com
  • Affiliation: Universidade de Fortaleza
  • Full name: Mariangela Freitas da Silveira
  • • Address: R. Gomes Carneiro, 1 - Centro, Pelotas - RS
    • City: Pelotas / Brazil
    • Zip code: 96010-610
  • Phone: +55-53 3284-3800
  • Email: mariangelafreitassilveira@gmail.com
  • Affiliation: Universidade Federal de Pelotas
   

Additional links:

• Previous revision

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