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