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

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.

Inclusion Criteria:

- Ability of subject to provide an informed consent

- Legally Authorized Representative-Adult must provide consent in case the subject is
unable to consent

- Diagnosis of Clostridium difficile disease based on clinical manifestations (change
in bowel habits, at least 2 more unformed bowel movements as compared to baseline
neurogenic bowel function in the same patient in the 24-hour period prior to
randomization)

- Lab data (positive polymerase chain reaction test for Clostridium difficile in a
stool specimen obtained within 72 hours before randomization)

- Patient has not received antibiotics that are active against Clostridium difficile
for any more than 24 hours prior to being screened for this study.

Exclusion Criteria:

- Receipt of agents (oral Vancomycin, oral or IV Metronidazole, oral rifamdin, oral
bacitracin, or oral fusidic acid) that are active against Clostridium difficile for
longer than 24 hours after randomization

- Life-threatening or fulminant Clostridium difficile infection, presence of toxic
megacolon, and history of inflammatory bowel disease (Crohn's disease and ulcerative
colitis)

- Allergy to study medications.