The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
19
Bezlotoxumab infusion
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Number of Participants With Recurrent C. Diff Infection at 90 Days
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Time frame: 90 days
Number of Participants With Recurrent C. Diff Infection at 12 Months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Time frame: 12 months
Number of Participants With Recurrent C. Diff Infection at 24 Months
Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.
Time frame: 24 months
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days
Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab.
Time frame: 90 days
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months
Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab
Time frame: 12 months
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months
Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab
Time frame: 24 months
Quality of Life and Disease Activity Scores of Participants at Study Baseline
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Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Time frame: Index visit
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Time frame: 90 Days
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Time frame: 12 months
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months
Quality of life and disease activity scores at baseline. Short Inflammatory Bowel disease questionnaire (SIBDQ) Scores range 0-70 Higher scores represent better disease related quality of life. Harvey Bradshaw Index (HBI) for CD patients and Ulcerative colitis disease activity (UCAI) for UC patients. Score ranging from 0 to 20. Patients with a score of 3 or less likely to be in remission.
Time frame: 24 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days
Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days.
Time frame: 90 Days
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months
Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months
Time frame: 12 months
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months
Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months
Time frame: 24 months