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

Clostridium Difficile Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02464306
• Other study ID #: 14-2257
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2018
• Est. completion date: June 2019

Study information

• Verified date: August 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Communicable Diseases
• Infection
• Solid Organ Transplant

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with a sustained clinical response (SCR), defined as clinical cure with no recurrence.		30 days