IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff

Inclusion Criteria

• •1. Males and female greater than 18 years of age
• •2. Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness
• •3. Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD
• •4. A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas.
• •CDSPS SCALE (each item is scored as one point for a 7 point maximum total)
• •1. underlying immunosuppression/chronic medical condition
• •2. altered or depressed mental status as defined by medical chart documentation
• •3. abdominal pain and/or distention
• •4. WBC \> 20,000 or \< 1,500 and/or bandemia \> 10%
• •5. hypoalbuminemia (\<3 mg/dL)
• •6. ascites (clinically or per CT scan findings per medical chart)
• •7. abnormal CT scan findings per medical chart -