NCT02355938

Use Of Oral Fidaxomicin Vs. Oral Vancomycin For Clostridium Difficile Infection In Patients With Spinal Cord Injury

Role of Fidaxomicin in a Patient Population With Problematic Clostridium Difficile Infection

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall costs of treatment of Clostridium difficile infection in the two study groups.

Detailed description

In recent clinical trials, comparing oral Vancomycin versus oral Fidaxomicin to treat Clostridium difficile, oral Fidaxomicin was shown to be the same in effectiveness as oral Vancomycin, but showed a decrease in recurrence of Clostridium difficile by ten percentage points. Based on experience with patients in our 40-bed spinal cord injury unit at the Michael E. DeBakey VA Medical Center (MEDVAMC), Clostridium difficile infection is more problematic in patients with spinal cord injury than in the general hospitalized patient population. Compared to the general population of hospitalized patients, patients with spinal cord injury are more likely to have: (1) a higher transmission of Clostridium difficile from one patient to another often via the health care worker due to their having a neurogenic bowel (2) a longer and more complicated course of Clostridium difficile infection-associated diarrhea since neurogenic bladder may delay excretion of toxins and predispose to bowel accidents; and (3) a higher overall cost of treatment in terms of extended hospitalization (most patients with spinal cord injury who suffer from Clostridium difficile infection do not get discharged from the hospital until the symptoms of course of Clostridium difficile infection are resolved. Fidaxomicin is the first in a new class of narrow spectrum macrocyclic antibiotic drugs. It is a non-systemic, meaning it is minimally absorbed into the bloodstream, and it is bactericidal, meaning it attacks and kills the bacteria it comes in contact with. It has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the numerous species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of recurrence of a Clostridium difficile infection. Since clearance of Clostridium difficile infections is problematic in the spinal cord injured patients, this antimicrobial agent may show a trend for clinical superiority and a reduction in recurrence of infection within the spinal cord injury population resulting in a shorter hospital stays and reduced costs.

Conditions

• Clostridium Difficile
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	Fidaxomicin 200 mg	Fidaxomicin 200 mg every 12 hours
DRUG	Placebo	1 dose of placebo every 6 hours x 2 doses
DRUG	Vancomycin	Vancomycin 125 mg every 6 hours

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-02-04
• Last updated: 2016-10-13

Locations

1 site across 1 country: United States