Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection

• Status: Withdrawn
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective study to assess the efficacy and safety of fidaxomicin in Solid Organ Transplant (SOT) recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of Clostridium difficile infection (CDI).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Fidaxomicin

Criteria

Inclusion Criteria:

• Age 18 or greater and up 85 years

• SOT recipient (lung, heart, kidney, liver, kidney-pancreas, pancreas)

• First episode of CDI

Exclusion Criteria:

• Receiving additional therapies with activity again C. difficile (oral bacitracin, fusidic acid, and/or rifaximin)

• Toxic megacolon

• Ileus or significant abdominal distension

• Hypotension with vasopressor requirement

• History of inflammatory bowel disease

• Pregnancy

• Decisionally challenged

• Prisoners

• >4 doses of metronidazole for the treatment of C. difficile in the previous 7 days

• >4 doses of oral vancomycin in the previous 7 days