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

Primary Purpose

Clostridium Difficile-associated Diarrhea (CDAD)

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
intravenous immunoglobulin G (IVIG)
Placebo
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile-associated Diarrhea (CDAD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc
  • UPMC Presbyterian Hospital
  • UPMC St. Margaret Hospital
  • UPMC Shadyside Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IVIG

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

1) 75% Reduction in Abdominal Pain/Tenderness
During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness
2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea
The quantity of anti-C. difficile antibodies with improve in relationship with recovery
3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea
A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.
4) Normalization of Neutrophil Count on CBC With Diff.
During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.
5) Normalization of Body Temperature During a 24 Hour Period
During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.
6) Patients' Length of Hospital Stay
During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.

Full Information

First Posted
September 13, 2005
Last Updated
September 14, 2016
Sponsor
University of Pittsburgh
Collaborators
Shadyside Hospital Foundation, Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00177970
Brief Title
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
Official Title
Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
We were unable to receive IVIG free from phamaceutical company.
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
Shadyside Hospital Foundation, Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
See "Brief Summary" for details

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile-associated Diarrhea (CDAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IVIG
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
intravenous immunoglobulin G (IVIG)
Other Intervention Name(s)
IVIG
Intervention Description
IVIG to be given IV to patients with C-Diff .
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to be given IV to patients with C-Diff
Primary Outcome Measure Information:
Title
1) Normalization of WBC's
Description
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
Time Frame
during the course of the study
Title
2) Decrease of Number of Loose Stools to <3 Per Day Following Treatment
Description
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).
Time Frame
during the course of the study
Secondary Outcome Measure Information:
Title
1) 75% Reduction in Abdominal Pain/Tenderness
Description
During the course of the study, we expect the IVIG group compared to the placebo group will a 75% reduction in abdominal pain/tenderness
Time Frame
during the course of the study
Title
2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea
Description
The quantity of anti-C. difficile antibodies with improve in relationship with recovery
Time Frame
during the course of the study
Title
3) Correlation Between Antibody Responses as Measured With ELISA (Enzyme Immunoassay) and Recovery of C. Difficile Diarrhea
Description
A correlation will occur between antibody responses as measured with ELISA (enzyme immunoassay) and recovery of C. difficile diarrhea.
Time Frame
during the course of the study
Title
4) Normalization of Neutrophil Count on CBC With Diff.
Description
During the course of the study, we expect the IVIG group compared to the placebo group will have normalization of neutrophil count (1.6-6.7)on CBC with diff.
Time Frame
during the course of the study
Title
5) Normalization of Body Temperature During a 24 Hour Period
Description
During the course of the study, we expect the IVIG group compared to the placebo group will have a normal body temperature of 98.6 F.
Time Frame
during the course of the study
Title
6) Patients' Length of Hospital Stay
Description
During the course of the study, we expect the IVIG group compared to the placebo group will have a decrease in length of hospital stay.
Time Frame
during the course of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L Arnold, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC St. Margaret Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
UPMC Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
records not available

Learn more about this trial

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

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