Status:
TERMINATED
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Shadyside Hospital Foundation
Bayer
Conditions:
Clostridium Difficile-associated Diarrhea (CDAD)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 f...
Detailed Description
See "Brief Summary" for details
Eligibility Criteria
Inclusion
- Males and female greater than 18 years of age
- Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness
- Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD
- 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)
- underlying immunosuppression/chronic medical condition
- altered or depressed mental status as defined by medical chart documentation
- abdominal pain and/or distention
- WBC \> 20,000 or \< 1,500 and/or bandemia \> 10%
- hypoalbuminemia (\<3 mg/dL)
- ascites (clinically or per CT scan findings per medical chart)
- abnormal CT scan findings per medical chart -
Exclusion
- Pregnant or lactating women
- Selective IgA deficiency
- Hypersensitivity to immune globulin, human albumin, or thimerosal -
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00177970
Start Date
October 1 2003
End Date
April 1 2008
Last Update
October 25 2016
Active Locations (4)
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1
UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc
Pittsburgh, Pennsylvania, United States, 15132
2
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
3
UPMC St. Margaret Hospital
Pittsburgh, Pennsylvania, United States, 15215
4
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232