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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02464306

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Clostridium Difficile Infection Solid Organ Transplant	Drug: fidaxomicin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: fidaxomicin Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days.
No Intervention: Historical Cohort Historical cohort of SOT recipients who received standard of care therapy for CDI at our institution.

Arm

Intervention/Treatment

Experimental: 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.

Drug: fidaxomicin

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

No Intervention: Historical Cohort

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Kelly E Schoeppler, PharmD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02464306

Other Study ID Numbers:

14-2257

First Posted:

Jun 8, 2015

Last Update Posted:

Aug 29, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Colorado, Denver

recipients

Additional relevant MeSH terms:

Infections

Communicable Diseases

Clostridium Infections

Fidaxomicin

Study Results

No Results Posted as of Aug 29, 2018