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

Phase 4

Withdrawn

• Conditions: Clostridium Difficile Infection; Solid Organ Transplant
• Interventions: Drug: fidaxomicin

• Registration Number: NCT02464306
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Study Start: 2018-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOT Recipients	fidaxomicin	SOT recipients (heart, lung, kidney, liver, kidney-pancreas, and pancreas) with a first-episode of CDI. 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.

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a sustained clinical response (SCR), defined as clinical cure with no recurrence.	30 days