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We were unable to receive IVIG free from phamaceutical company.
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| Name | Class |
|---|---|
| Shadyside Hospital Foundation | OTHER |
| Bayer | INDUSTRY |
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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.
See "Brief Summary" for details
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous immunoglobulin G (IVIG) | Drug | IVIG to be given IV to patients with C-Diff . |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during the course of the study |
| 2) Quantity of Anti-C. Difficile Antibodies in Relationship With Recovery of C. Difficile Diarrhea |
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Inclusion Criteria:
CDSPS SCALE (each item is scored as one point for a 7 point maximum total)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George L Arnold, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC McKeesport Hospital and SemperCare Hospital of McKeesport, Inc | Pittsburgh | Pennsylvania | 15132 | United States | ||
records not available
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Enrollment number retrieved from old IRB database and not from study records and cannot be verified.
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| ID | Title | Description |
|---|---|---|
| FG000 | IVIG | intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff . |
| FG001 | Placebo | Placebo: Placebo to be given IV to patients with C-Diff |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No results available record destroyed due to age of study. no publications
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| ID | Title | Description |
|---|---|---|
| BG000 | IVIG | intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff . |
| BG001 | Placebo | Placebo: Placebo to be given IV to patients with C-Diff |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | No results available record destroyed due to age of study. no publications |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
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No results available. Records were destroyed due to age of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IVIG | intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff . |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George Arnold | UPittsburgh | 4126212334 | arnoldgl@upmc.edu |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | Placebo to be given IV to patients with C-Diff |
|
The quantity of anti-C. difficile antibodies with improve in relationship with recovery |
| during the course of the study |
| 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. | during the course of the study |
| 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. | during the course of the study |
| 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. | during the course of the study |
| 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. | during the course of the study |
| UPMC Presbyterian Hospital |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| UPMC St. Margaret Hospital | Pittsburgh | Pennsylvania | 15215 | United States |
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Primary | 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). | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| Secondary | 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 | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| Secondary | 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 | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| Secondary | 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. | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| Secondary | 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. | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| Secondary | 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. | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| Secondary | 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. | No results available record destroyed due to age of study. no publications | Posted | during the course of the study |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo: Placebo to be given IV to patients with C-Diff | 0 | 0 | 0 | 0 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |