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

Sponsors and Collaborators:	University of Pittsburgh Shadyside Hospital Foundation Bayer
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00177970

Purpose

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.

Condition	Intervention	Phase
Clostridium Difficile-Associated Diarrhea (CDAD)	Drug: intravenous immunoglobulin G (IVIG)	Phase IV

MedlinePlus related topics: Abdominal Pain Diarrhea

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

1) normalization of WBC's
2) decrease of number of loose stools to <3 per day following treatment

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	October 2003
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

Pregnant or lactating women
Selective IgA deficiency
Hypersensitivity to immune globulin, human albumin, or thimerosal -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177970

Locations

United States, Pennsylvania
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc
Pittsburgh, Pennsylvania, United States, 15132
UPMC St. Margaret Hospital
Pittsburgh, Pennsylvania, United States, 15215
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Shadyside Hospital Foundation

Bayer

Investigators

Principal Investigator:

George L Arnold, MD

University of Pittsburgh

More Information

Responsible Party:	UPMC Shadyside Hospital ( George Arnold, MD, FACP )
Study ID Numbers:	0311034
Study First Received:	September 13, 2005
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00177970
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Antibodies
Diarrhea
Signs and Symptoms, Digestive
Immunoglobulins, Intravenous

Immunoglobulin G
Rho(D) Immune Globulin
Colitis
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009