A Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Overview

Información sobre este estudio

608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

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.

To be included in this study, participants must:

  • Sign a consent form;
  • Be older 18 or older and 90 or younger;
  • Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
  • Test positive for Clostridium difficile;
  • If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.

Participants will not be allowed into the study if they:

  • Have toxic megacolon and/or known small bowel ileus;
  • Have received treatment with intravenous immune globulin (IVIG)within the past 30 days;
  • Have received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
  • Have received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
  • Have received an investigational vaccine against C. difficile;
  • Have received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
  • Had more than 2 episodes of CDAD within 90 days;
  • Had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months(this does not include appendectomy or cholecystectomy);
  • Have history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
  • Are unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
  • Are unable to discontinue opiate treatment unless on a stable dose;
  • Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
  • Had stool studies positive for pathogenic ova and/or parasites;
  • Have an intolerance or hypersensitivity to daptomycin and/or vancomycin;
  • Have life-threatening illness at the time of enrollment;
  • Have poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
  • Have received an investigational drug or participated in any experimental procedure within 1 month;
  • Have HIV, a CD4 <200 cells/mm3 within 6 months of start of study therapy;
  • Anticipate that certain antibacterial therapy for a non-CDAD infection will be required for >7 days;
  • Are unable to discontinue Saccharomyces or similar probiotic;
  • Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
  • Are unable to comply with the protocol requirements;
  • Have any condition that, in the opinion of the Investigator, might interfere;
  • Are not expected to live for less than 8 weeks.

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

Seth Sweetser, 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