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

NCT02464306 | Withdrawn Phase 4

• 1 other identifier: 14-2257
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Clostridium Difficile Infection; Solid Organ Transplant

Keywords

recipients

Outcome Measures

Primary Outcomes (1)

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

  30 days

Study Arms (2)

SOT Recipients

EXPERIMENTAL

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

Historical Cohort

NO INTERVENTION

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

Interventions

fidaxomicin DRUG

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

SOT Recipients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater and up 85 years
• SOT recipient (lung, heart, kidney, liver, kidney-pancreas, pancreas)
• First episode of CDI

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Kelly E Schoeppler, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: June 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08