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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02464306

Enrollment

Registered

2015-06-08

Start date

2018-06-30

Completion date

2019-06-30

Last updated

2018-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection, Solid Organ Transplant

Keywords

recipients

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.

Interventions

DRUGfidaxomicin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026