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

Status:	Terminated
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	October 2003
End Date:	April 2008

Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis

In this trial, eligible patients will be randomly assigned to receive a single dose of 400
mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their
usual medications for CDAD. We expect to enroll approximately 40 patients over a period of
two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who
are unresponsive to standard antimicrobial therapy for CDAD.

During the course of this study we expect that IVIG group compared with placebo group will
have fewer number of stools per day (< 3 per day). Secondary endpoints will include normal
WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and
decrease in length of hospital stay.

Subjects will sign a written informed consent prior to any study procedures. Patients will
be monitored closely during the infusion of the study medication and will continue to be
monitored on a daily basis up to the time of discharge. Data collection will include vital
signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.

See "Brief Summary" for details

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 -

Exclusion Criteria:

1. Pregnant or lactating women

2. Selective IgA deficiency

3. Hypersensitivity to immune globulin, human albumin, or thimerosal -

We found this trial at

sites

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania 15216

from

Pittsburgh, PA