Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections
Conditions
Keywords
C.diff, C. difficile, IBD, UC, Bezlotoxumab, Recurrent C. diff
Brief summary
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Detailed description
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.
Interventions
BIOLOGICALBezlotoxumab
Bezlotoxumab infusion
Sponsors
Merck Sharp & Dohme LLC
David Binion, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years old * active CDI receiving therapy * diagnosis of IBD * and history of CDI.
Exclusion criteria
* \<18 years old * no IBD * no CDI * history of colectomy * history of preexisting congestive heart failure * pregnant or nursing women * TCP\<50 * past cardiac history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrent C. Diff Infection at 90 Days | 90 days | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. |
| Number of Participants With Recurrent C. Diff Infection at 12 Months | 12 months | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. |
| Number of Participants With Recurrent C. Diff Infection at 24 Months | 24 months | Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months | 12 months | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months |
| Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months | 24 months | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months |
| Quality of Life and Disease Activity Scores of Participants at Study Baseline | Index visit | 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. |
| Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days | 90 days | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab. |
| Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months | 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. |
| Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months | 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. |
| Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days | 90 Days | Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days. |
| Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days | 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. |
| Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months | 12 months | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab |
| Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months | 24 months | Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab |
Countries
United States
Participant flow
Recruitment details
Patients who are part of the IBD Registry and have a defined IBD diagnosis and CDI will be approached to be consented for this study.
Pre-assignment details
Randomly the study treatment will be offered to 50 patients.
Participants by arm
| Arm | Count |
|---|---|
| Open Label Bezlotuxumab Single arm Bezlotoxumab infusion | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated | 14 |
Baseline characteristics
| Characteristic | Open Label Bezlotuxumab |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 12 |
| IBD Type Crohn's disease (CD) | 14 participants |
| IBD Type Ulcerative Colitis (UC) | 5 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Bezlotuxumab | Number of Participants With Recurrent C. Diff Infection at 12 Months | 1 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Bezlotuxumab | Number of Participants With Recurrent C. Diff Infection at 24 Months | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Bezlotuxumab | Number of Participants With Recurrent C. Diff Infection at 90 Days | 1 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Label Bezlotuxumab | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months | CRP | 0 Participants |
| Open Label Bezlotuxumab | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months | ESR | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Label Bezlotuxumab | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months | CRP | 1 Participants |
| Open Label Bezlotuxumab | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months | ESR | 1 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Open Label Bezlotuxumab | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days | CRP | 6 Participants |
| Open Label Bezlotuxumab | Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days | ESR | 8 Participants |
Secondary
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
Population: CD=7, UC=1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months | SIBDQ | 49.75 score on a scale | Standard Deviation 18 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months | HBI | 7.5 score on a scale | Standard Deviation 5.6 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months | UCAI | 3 score on a scale | Standard Deviation 0 |
Secondary
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
Population: CD=4, UC=1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months | SIBDQ | 61.8 score on a scale | Standard Deviation 6 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months | HBI | 3.7 score on a scale | Standard Deviation 2.6 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months | UCAI | 0 score on a scale | Standard Deviation 0 |
Secondary
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
Population: CD=12, UC=5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days | SIBDQ | 40 score on a scale | Standard Deviation 18.08 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days | HBI | 6.5 score on a scale | Standard Deviation 6.1 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days | UCAI | 2.6 score on a scale | Standard Deviation 1.8 |
Secondary
Quality of Life and Disease Activity Scores of Participants at Study Baseline
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
Population: 14 CD, 5 UC
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants at Study Baseline | SIBDQ | 40.8 score on a scale | Standard Deviation 14.02 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants at Study Baseline | HBI | 8.6 score on a scale | Standard Deviation 5.2 |
| Open Label Bezlotuxumab | Quality of Life and Disease Activity Scores of Participants at Study Baseline | UCAI | 6.2 score on a scale | Standard Deviation 5.7 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Bezlotuxumab | Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months | ED visits | 6 Ocurrences |
| Open Label Bezlotuxumab | Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months | Hospital admissions | 2 Ocurrences |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Bezlotuxumab | Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months | ED visits | 1 Ocurrences |
| Open Label Bezlotuxumab | Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months | Hospital admissions | 2 Ocurrences |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label Bezlotuxumab | Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days | ED visits | 10 Ocurrences |
| Open Label Bezlotuxumab | Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days | Hospital admissions | 4 Ocurrences |