IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Difficile-Associated Diarrhea (CDAD)
Intervention: intravenous immunoglobulin G (IVIG) (Drug)
Phase: Phase 4
Sponsored by: University of Pittsburgh
Official(s) and/or principal investigator(s):
George L Arnold, MD, Principal Investigator, Affiliation: University of Pittsburgh
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.
Official title: Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis
Study design: Randomized, Double-Blind, Placebo Control, Single Group Assignment
1) normalization of WBC's
2) decrease of number of loose stools to <3 per day following treatment
1) Time to improvement of abdominal pain/tenderness
2) Quantity of anti-C. difficile antibodies in relationship with recovery of C. difficile diarrhea
3) Correlation between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea
4) normalization of neutrophil count on CBC with diff.
5) normalization of body temperature during a 24 hour period
6) patients' length of hospital stay
Minimum age: 18 Years.
Maximum age: N/A.
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
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 -
1. Pregnant or lactating women
2. Selective IgA deficiency
3. Hypersensitivity to immune globulin, human albumin, or thimerosal -
Locations and Contacts
UPMC Shadyside Hospital, Pittsburgh, Pennsylvania 15232, United States
UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc, Pittsburgh, Pennsylvania 15132, United States
UPMC St. Margaret Hospital, Pittsburgh, Pennsylvania 15215, United States
UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania 15213, United States
Starting date: October 2003
Ending date: July 2007
Last updated: April 3, 2008