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

August 27, 2018 updated by: University of Colorado, Denver
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-2257

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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