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

NCT00177970 | Terminated Phase 4 Results DMC

• 1 other identifier: 0311034
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Clostridium Difficile-associated Diarrhea (CDAD)

Outcome Measures

Primary Outcomes (2)

• 1) Normalization of WBC's

  During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM

  during the course of the study

• 2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment

  During the course of the study, we expect the IVIG group compared to the placebo group will have fewer number of stools per day (\<3 per day).

  during the course of the study

Secondary Outcomes (6)

• 1) 75% Reduction in Abdominal Pain/Tenderness

  during the course of the study

• 2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea

  during the course of the study

• 3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea

  during the course of the study

• 4) Normalization of Neutrophil Count on CBC With Diff.

  during the course of the study

• 5) Normalization of Body Temperature During a 24 Hour Period

  during the course of the study

Study Arms (2)

IVIG

ACTIVE COMPARATOR

Drug: intravenous immunoglobulin G (IVIG)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

intravenous immunoglobulin G (IVIG) DRUG

IVIG to be given IV to patients with C-Diff .

Also known as: IVIG

IVIG

Placebo DRUG

Placebo to be given IV to patients with C-Diff

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Shadyside Hospital Foundation: collaborator
• Bayer: collaborator

Study Sites (4)

UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc

Pittsburgh, Pennsylvania, 15132, United States

Location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC St. Margaret Hospital

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. George Arnold
• Organization: UPittsburgh

arnoldgl@upmc.edu

4126212334

Study Officials

• George L Arnold, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 25, 2016
• Results First Posted: July 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)