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

NCT ID: NCT02464306

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2019-06-30

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.

Conditions

Clostridium Difficile Infection; Solid Organ Transplant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOT Recipients

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.

Group Type: EXPERIMENTAL

fidaxomicin

Intervention Type: DRUG

Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days.

Historical Cohort

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

fidaxomicin

Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly E Schoeppler, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

14-2257

Identifier Type: -

Identifier Source: org_study_id