Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

Overview

Información sobre este estudio

The purpose of this study is to confirm the effectiveness of RBX2660 as compared to a placebo in preventing recurrent episodes of Clostridium difficile Infection (CDI) through 8 weeks.

 

 

 

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:

  1. ≥ 18 years old.
  2. Medical record documentation of recurrent CDI per the study definition, that includes either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization within the last year.
  3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior to or on the date of enrollment.
  4. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea at the time of enrollment.

[Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while taking this course of antibiotics]

Exclusion Criteria:

  1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI treatment.
  2. Previous fecal transplant
  3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
  4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.
  5. Compromised immune system (e.g. immunosuppressed due to a medical condition or medication; current or recent (< 90 days) treatment with chemotherapy)
  6. An absolute neutrophil count of <1000 cells/µL during screening.
  7. Pregnant, breastfeeding, or intends to become pregnant during study participation.

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

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Robert Orenstein, D.O.

Cerrado para la inscripción

More information

Publicaciones

  • Clostridium difficile infection (CDI) continues to be a frequent and potentially severe infection. There is currently no validated clinical tool for use at the time of CDI diagnosis to categorize patients in order to predict response to therapy. Read More on PubMed

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