Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Estudio para evaluar la seguridad, tolerabilidad y eficacia de Afabicin en el tratamiento de participantes con infección ósea o articular por estafilococos

7 de septiembre de 2026 actualizado por: Debiopharm International SA

Estudio abierto aleatorizado con control activo para evaluar la seguridad, la tolerabilidad y la eficacia de Afabicin IV/oral en el tratamiento de pacientes con infección ósea o articular por estafilococo

Este es un estudio abierto, aleatorizado, con control activo para evaluar la seguridad, tolerabilidad y eficacia de Afabicin en el tratamiento de participantes con infección ósea o articular debido a Staphylococcus aureus [tanto S. aureus sensible a la meticilina (MSSA) como meticilina -S. aureus resistente (MRSA)] y/o estafilococos coagulasa negativos (CoNS) y compararlo con el estándar de atención (SOC).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

67

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Diagnóstico de infección ósea o articular que cumpla las siguientes condiciones: a) La infección se debe únicamente a S. aureus (MSSA o MRSA) y/o CoNS; y b) los participantes no habían recibido más de 7 días de antibióticos empíricos antes de iniciar el tratamiento con el fármaco del estudio, a menos que el patógeno aislado fuera resistente a los antibióticos empíricos administrados; y, c) el biofilm aún no se considera establecido y/o ha sido erradicado mecánicamente; y, d) La infección no está asociada con un pie diabético; y, e) La infección puede afectar el periostio o los tejidos blandos.

Criterio de exclusión:

  • Presencia de coinfección con bacterias no estafilocócicas en la articulación u hueso afectado, o en la sangre.
  • Participantes con mayor riesgo de desarrollar daño hepático.
  • Choque circulatorio o cualquier condición médica asociada con riesgo agudo de muerte.
  • Esperanza de vida inferior a 1 año.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: Afabicin
Administrado por vía intravenosa y por vía 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.
Droga: Afabicin
Administrado por vía intravenosa y por vía oral.
Comparador activo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.
Comparador activo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: 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.
Droga: Afabicin
Administrado por vía intravenosa y por vía 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.
Droga: Afabicin
Administrado por vía intravenosa y por vía oral.
Comparador activo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.
Comparador activo: 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.
Droga: Cefazolin
Administered intravenously.
Droga: Vancomycin
Administered intravenously.
Droga: Linezolid
Administered intravenously and orally.
Droga: Clindamycin
Administered intravenously and orally.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Clinical Response
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Debiopharm International SA

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de febrero de 2019

Finalización primaria (Actual)

23 de abril de 2025

Finalización del estudio (Actual)

23 de abril de 2025

Fechas de registro del estudio

Enviado por primera vez

26 de octubre de 2018

Primero enviado que cumplió con los criterios de control de calidad

26 de octubre de 2018

Publicado por primera vez (Actual)

29 de octubre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir