NCT02464306

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days. The rate of sustained clinical response (SCR; cure without recurrence at 30 days) will be assessed and compared to a historical cohort of SOT recipients who received standard of care therapy for CDI at our institution. The data for the historical control group will be collected under a separate IRB-approved protocol. Standard of care therapy will be considered oral or intravenous metronidazole and / or oral vancomycin. The study will be powered to show non-inferiority of fidaxomicin compared to standard of care treatment in SOT recipients.

Conditions

• Clostridium Difficile Infection
• Solid Organ Transplant

Interventions

Type	Name	Description
DRUG	fidaxomicin	Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days.

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2015-06-08
• Last updated: 2018-08-29