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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02464306
Other study ID # 14-2257
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
See also
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