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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

Status: Completed

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
George L Arnold, MD, Principal Investigator, Affiliation: University of Pittsburgh

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 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.

Clinical Details

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

Primary outcome:

1) normalization of WBC's

2) decrease of number of loose stools to <3 per day following treatment

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 -

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

Additional Information

Starting date: October 2003
Ending date: July 2007
Last updated: April 3, 2008

Page last updated: June 20, 2008

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