| Registry | NCT02464306 |
|---|---|
| Status | Withdrawn - Lost funding |
| Phase | Phase 4 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Sponsor | University of Colorado, Denver (Other) |
| Conditions | Clostridium Difficile Infection, Solid Organ Transplant |
| Interventions | fidaxomicin (Drug) |
| Dates | start 2018-06-01 (estimated), primary completion 2018-12-01 (estimated), completion 2019-06-01 (estimated), first posted 2015-06-08, last updated 2018-08-29 |
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All trials for Clostridium Difficile Infection All trials for Solid Organ Transplant All trials of fidaxomicin
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SOT Recipients | Experimental | Drug: 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. |
| Historical Cohort | No intervention | Historical cohort of SOT recipients who received standard of care therapy for CDI at our institution. |
Sex: All, ages: 18 Years to 85 Years
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