IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
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ClinicalTrials.gov Identifier: NCT00177970 |
Recruitment Status :
Terminated
(We were unable to receive IVIG free from phamaceutical company.)
First Posted : September 15, 2005
Results First Posted : July 15, 2016
Last Update Posted : October 25, 2016
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Clostridium Difficile-associated Diarrhea (CDAD) | Drug: intravenous immunoglobulin G (IVIG) Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: IVIG |
Drug: intravenous immunoglobulin G (IVIG)
IVIG to be given IV to patients with C-Diff .
Other Name: IVIG |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo to be given IV to patients with C-Diff |
- 1) Normalization of WBC's [ Time Frame: during the course of the study ]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 [ Time Frame: during the course of the study ]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).
- 1) 75% Reduction in Abdominal Pain/Tenderness [ Time Frame: during the course of the study ]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 [ Time Frame: during the course of the study ]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 [ Time Frame: during the course of the study ]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. [ Time Frame: during the course of the study ]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 [ Time Frame: during the course of the study ]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 [ Time Frame: during the course of the study ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 -

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177970
United States, Pennsylvania | |
UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc | |
Pittsburgh, Pennsylvania, United States, 15132 | |
UPMC Presbyterian Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
UPMC St. Margaret Hospital | |
Pittsburgh, Pennsylvania, United States, 15215 | |
UPMC Shadyside Hospital | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | George L Arnold, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177970 |
Other Study ID Numbers: |
0311034 |
First Posted: | September 15, 2005 Key Record Dates |
Results First Posted: | July 15, 2016 |
Last Update Posted: | October 25, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | records not available |
Diarrhea Signs and Symptoms, Digestive Immunoglobulins Immunoglobulins, Intravenous Antibodies |
Immunoglobulin G gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |