Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection

Overview

Información sobre este estudio

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

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:

  • Willing to provide informed consent.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Documented diagnosis of at least one CDI within the last 180 days with treatment completed.
  • Currently receiving systemic antibiotics for a non-CDI condition with anticipated duration of no more than 2 weeks.
  • Females of childbearing potential must have a negative pregnancy test prior to randomization and agree to use adequate contraception prior to randomization, for the duration of the study, and for 4 weeks following study completion.
  • Have received no more than 72 hours of non-CDI antibiotics.

Exclusion Criteria:

  • History of hypersensitivity or allergy to oral vancomycin.
  • Current use of oral vancomycin.
  • Patients on concurrent treatment with metronidazole or tetracycline monotherapy for any indication.
  • Patients diagnosed with inflammatory bowel disorder (Crohn's disease), or bacterial gastrointestinal infection cause by agents other than C. difficile (e.g., Salmonella sp.), toxic megacolon and/or known small bowel ileus.
  • Dysphagia (inability to swallow capsules) or unwilling to swallow capsules.
  • Major gastrointestinal surgery within 3 months of enrollment (does not include appendectomy or cholecystectomy).
  • Any history of total colectomy or bariatric surgery.
  • Unable or unwilling to fulfill study requirements.
  • Expected life expectancy < 6 months.
  • Patients enrolled in another clinical trial with investigational drugs within 30 days prior to randomization.
  • Women who are pregnant or breast-feeding.
  • Any patient deemed not suitable for study participation at the discretion of the study investigator.
  • Diarrhea (3 or more loose stools in a 24 hour period) at enrollment.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

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 Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Sahil Khanna, M.B.B.S., M.S.

Cerrado para la inscripción

Contact information:

Rebecca Hofschulte CRCST

(507) 284-9709

Hofschulte.Rebecca@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20521365

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