An Extension of a Previous Study Evaluating the Use of SER-109 to Prevent Recurrent Clostridium Difficile Infections

Overview

Información sobre este estudio

The purpose of this study is to extend the previous SERES-004 study in patients who had a recurrence of clostridium difficile infection within the first 8 weeks of participation.  

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria

  • Previously enrolled in study SERES 004 and had Clostridium Difficile infection recurrence within 8 weeks after receipt of study drug
  • Signed informed consent, indicating that the patient understands the purpose of and procedures required for the study
  • Antibiotic regimen (for the most recent CDI episode) should be14 days of oral vancomycin (125 mg, q6h) or 10 days of oral fidaxomicin (200 mg, q12h) with adequate clinical response before treatment with SER 109

 

Exclusion Criteria

  • Female patients who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study
  • Known or suspected toxic megacolon and/or known small bowel ileus
  • Active irritable bowel syndrome with diarrhea within the previous 12 months
  • Major GI surgery (eg, significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy) or any history of total colectomy or bariatric surgery
  • History of inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 24 months
  • Admitted to or expected to be admitted to an acute care facility or intensive care unit for medical reasons (not just boarding)
    • Patients discharged from an acute care facility before day 1 or residing in nursing homes or rehabilitation facilities may be enrolled
  • Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (patients on maintenance chemotherapy may only be enrolled after consultation with medical monitor)

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Darrell Pardi, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos que no son sobre cáncer

Teléfono: 800-664-4542 (llamada gratis)

Preguntas de estudios clínicos para pacientes internacionales