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

Primary Purpose

Clostridium Difficile Infection, Solid Organ Transplant

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

fidaxomicin

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring recipients

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SOT Recipients

Historical Cohort

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02464306

First Posted

June 3, 2015

Last Updated

August 27, 2018

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT02464306

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Lost funding

Study Start Date

June 2018 (Anticipated)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

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.

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile Infection, Solid Organ Transplant

Keywords

recipients

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOT Recipients

Arm Type

Experimental

Arm Description

Arm Title

Historical Cohort

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

fidaxomicin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly E Schoeppler, PharmD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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