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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Clostridium Difficile Infection, Solid Organ Transplant

Intervention / Treatment
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* Drug: fidaxomicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOT Recipients<br>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. | Drug: fidaxomicin<br>* Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days.<br>|
| No Intervention: Historical Cohort<br>Historical cohort of SOT recipients who received standard of care therapy for CDI at our institution. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with a sustained clinical response (SCR), defined as clinical cure with no recurrence. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recipients