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

University of Colorado Denver (CU Denver)

Status and phase: Withdrawn; Phase 4

Conditions: Solid Organ Transplant; Clostridium Difficile Infection

Treatments: Drug: fidaxomicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02464306

14-2257

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

SOT Recipients

Experimental group

Description:

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.

Treatment:

Drug: fidaxomicin

Historical Cohort

No Intervention group

Description:

Historical cohort of SOT recipients who received standard of care therapy for CDI at our institution.