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Estudo para Avaliar a Segurança, Tolerabilidade e Eficácia da Afabicina no Tratamento de Participantes com Infecção Óssea ou Articular Devido a Staphylococcus

7 de setembro de 2026 atualizado por: Debiopharm International SA

Estudo Aberto Randomizado de Controle Ativo para Avaliar a Segurança, Tolerabilidade e Eficácia da Afabicina IV/Oral no Tratamento de Pacientes com Infecção Óssea ou Articular Devido a Staphylococcus

Este é um estudo aberto randomizado, controlado por ativo para avaliar a segurança, tolerabilidade e eficácia de Afabicina no tratamento de participantes com infecção óssea ou articular devido a Staphylococcus aureus [S. aureus suscetível à meticilina (MSSA) e meticilina -resistente S. aureus (MRSA)] e/ou estafilococos coagulase-negativos (CoNS) e compará-lo com o tratamento padrão (SOC).

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

67

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Geórgia
      • Akhalts'ikhe, Geórgia, 0800
        • Georgian Clinics JSC
      • Kutaisi, Geórgia, 4600
        • West Georgia Medical Center LLC
      • Tbilisi, Geórgia, 0141
        • LEPL The First University Clinic of Tbilisi State Medical University
      • Tbilisi, Geórgia, 0144
        • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
      • Tbilisi, Geórgia, 0101
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
      • Tbilisi, Geórgia, 0160
        • Academician Vakhtang Bochorishvili Clinic LTD
      • Tbilisi, Geórgia, 0186
        • Caucasus Medical Center LLC
  • Ucrânia
      • Dnipro, Ucrânia, 49027
        • Dnipropetrovsk Regional Clinical Hospital
      • Ivano-Frankivsk, Ucrânia, 76008
        • Regional Clinical Hospital under Ivano-Frankivsk Regional Council
      • Kharkiv, Ucrânia, 61176
        • Kharkiv Regional Clinical Traumatology Hospital
      • Kyiv, Ucrânia, 04107
        • Kyiv Regional Clinical Hospital
      • Kyiv, Ucrânia, 01601
        • Institute of Traumatology and Orthopedics
      • Kyiv, Ucrânia
        • Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
      • Vinnytsia, Ucrânia, 21028
        • Vinnytsya Regional Clinical Hospital
      • Vynnyky, Ucrânia, 79495
        • Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
      • Zaporizhia, Ucrânia, 69065
        • City Hospital #9 under Zaporizhia City Council
  • África do Sul
      • Benoni, África do Sul, 1500
        • Worthwhile Clinical Trials, Lakeview Hospital
      • Pretoria, África do Sul, 0002
        • Clinical Research Unit, University of Pretoria
      • Pretoria, África do Sul, 0157
        • Global Clinical Trials (Pty) Ltd

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Diagnóstico de infecção óssea ou articular que preencha as seguintes condições: a) A infecção é causada apenas por S. aureus (MSSA ou MRSA) e/ou CoNS; e, b) Os participantes não receberam mais de 7 dias de antibióticos empíricos antes de iniciar o tratamento com o medicamento do estudo, a menos que o patógeno isolado fosse resistente aos antibióticos empíricos administrados; e, c) O biofilme não é considerado ainda estabelecido e/ou foi erradicado mecanicamente; e, d) A infecção não está associada ao pé diabético; e, e) A infecção pode envolver tecidos moles ou periosteais.

Critério de exclusão:

  • Presença de co-infecção com bactérias não estafilocócicas no local da articulação ou osso afetado ou no sangue.
  • Participantes com risco aumentado de desenvolver lesão hepática.
  • Choque circulatório ou qualquer condição médica associada a risco agudo de morte.
  • Expectativa de vida inferior a 1 ano.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Part A: Afabicin: Cohort 1
Participants received afabicin intravenously (IV) at a dose of 160 milligrams (mg), twice daily (BID), followed by a switch to oral afabicin at a dose of 240 mg, BID, for 2-3 weeks.
Medicamento: Afabicina
Administrado por via intravenosa e oral.
Experimental: Part A: Afabicin: Cohort 2
Participants received afabicin IV at a dose of 160 mg, BID, followed by a switch to oral afabicin at a dose of 240 mg, BID, for 3-6 weeks.
Medicamento: Afabicina
Administrado por via intravenosa e oral.
Comparador Ativo: Part A: SoC: Cohort 1
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicamento: Cefazolin
Administered intravenously.
Medicamento: Vancomycin
Administered intravenously.
Medicamento: Linezolid
Administered intravenously and orally.
Medicamento: Clindamycin
Administered intravenously and orally.
Comparador Ativo: Part A: SoC: Cohort 2
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicamento: Cefazolin
Administered intravenously.
Medicamento: Vancomycin
Administered intravenously.
Medicamento: Linezolid
Administered intravenously and orally.
Medicamento: Clindamycin
Administered intravenously and orally.
Experimental: Part B: Afabicin: Cohort 1
Participants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 2-3 weeks.
Medicamento: Afabicina
Administrado por via intravenosa e oral.
Experimental: Part B: Afabicin: Cohort 2
Participants received afabicin IV at a dose of 55 mg, BID, followed by a switch to oral afabicin at a dose of 80 mg, BID, for 3-6 weeks.
Medicamento: Afabicina
Administrado por via intravenosa e oral.
Comparador Ativo: Part B: SoC: Cohort 1
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicamento: Cefazolin
Administered intravenously.
Medicamento: Vancomycin
Administered intravenously.
Medicamento: Linezolid
Administered intravenously and orally.
Medicamento: Clindamycin
Administered intravenously and orally.
Comparador Ativo: Part B: SoC: Cohort 2
Participants with oxacillin-/methicillin-susceptible staphylococci were administered with either cefazolin or vancomycin or linezolid or clindamycin, IV or linezolid or clindamycin, orally; participants with oxacillin-/methicillin-resistant staphylococci were administered either vancomycin or clindamycin or linezolid, IV or linezolid or clindamycin, orally, as part of SoC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
Medicamento: Cefazolin
Administered intravenously.
Medicamento: Vancomycin
Administered intravenously.
Medicamento: Linezolid
Administered intravenously and orally.
Medicamento: Clindamycin
Administered intravenously and orally.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: Up to Day 142
Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. TEAE is any undesirable event either not present prior to medical treatment or worsening (in intensity or frequency) following treatment. SAE is defined as any untoward medical occurrence that at any dose: results in death; is life-threatening (i.e., puts the patient at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is otherwise medically significant.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Hematology Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03
Prazo: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Clinical Chemistry Parameters Based on NCI-CTCAE v4.03
Prazo: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Electrolyte Parameters Based on NCI-CTCAE v4.03
Prazo: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Grade Shift From Baseline in Coagulation Parameters Based on NCI-CTCAE v4.03
Prazo: Up to Day 142
Laboratory abnormalities were graded according to NCI CTCAE v4.03. Grade 0 indicates a normal value; Grades 1-4 represent increasing severity of abnormalities outside the normal range. "High" and "Low" indicate values above and below the normal range, respectively. At baseline (last assessment prior to randomization), both "High, Grade 0" and "Low, Grade 0" indicate normal values and identify the direction of the subsequent post-baseline shift. Participants were evaluated separately for High and Low shifts. Participant could contribute to both analyses if shifts occurred in opposite directions at different assessments. These categories are not mutually exclusive; therefore, counts should not be summed across directions, as they may exceed the number of participants analyzed. Participant could not be classified as both High and Low at the same assessment. Only categories with at least one participant showing a shift were reported.
Up to Day 142
Number of Participants With Post-baseline Clinically Significant Urinalysis Abnormalities
Prazo: Up to Day 142
Clinical significance of abnormalities in urinalysis was determined based on the investigator's discretion. Baseline is defined as the last assessment prior to the randomization.
Up to Day 142

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Clinical Response
Prazo: Part A: At Day 8, EOT (up to Day 22), 4-weeks post-EOT (up to Day 50), and 12-weeks post-EOT (up to Day 130); Part B: At Day 8, Day 28, Day 42, EOT (up to Day 43), 4-weeks post-EOT (up to Day 73), and 12-weeks post-EOT (up to Day 142)
Clinical response was based on the improvement of disease-specific signs and symptoms. Responders are defined as participants meeting all the following criteria: improvement of disease-specific signs and symptoms and no new signs, symptoms or complications attributable to the initial infection; No evidence of drainage, sinus tract formation or infection-related bone instability; No requirement for subsequent antibiotics with activity against Staphylococcus to treat the initial infection after the start of study treatment; Microbiological eradication of the baseline pathogen (if post-baseline sample[s] are available); Imaging test at 12 weeks post-EOT showing no worsening of baseline pathology or presence of signs indicating resolution or healing of the infection. Percentages are rounded off.
Part A: At Day 8, EOT (up to Day 22), 4-weeks post-EOT (up to Day 50), and 12-weeks post-EOT (up to Day 130); Part B: At Day 8, Day 28, Day 42, EOT (up to Day 43), 4-weeks post-EOT (up to Day 73), and 12-weeks post-EOT (up to Day 142)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Debiopharm International SA

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de fevereiro de 2019

Conclusão Primária (Real)

23 de abril de 2025

Conclusão do estudo (Real)

23 de abril de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

26 de outubro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de outubro de 2018

Primeira postagem (Real)

29 de outubro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

7 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Debio 1450-BJI-205
  • 2017-002854-35 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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