Trial Outcomes & Findings for Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD). (NCT NCT04626947)

Results Overview

Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

90 days

Results posted on

2025-06-05

Participant Flow

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.

Randomly the study treatment will be offered to 50 patients.

Participant milestones

Participant milestones
Measure	Open Label Bezlotuxumab Single arm Bezlotoxumab infusion
Overall Study STARTED	19
Overall Study 90 Days	17
Overall Study 12 Months	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Bezlotuxumab Single arm Bezlotoxumab infusion
Overall Study Study terminated	14

Baseline Characteristics

Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Bezlotuxumab n=19 Participants Single arm Bezlotoxumab infusion
Age, Continuous	51 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
IBD Type Crohn's disease (CD)	14 participants n=5 Participants
IBD Type Ulcerative Colitis (UC)	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=17 Participants Single arm Bezlotoxumab infusion
Number of Participants With Recurrent C. Diff Infection at 90 Days	1 Participants

PRIMARY outcome

Timeframe: 12 months

Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=8 Participants Single arm Bezlotoxumab infusion
Number of Participants With Recurrent C. Diff Infection at 12 Months	1 Participants

PRIMARY outcome

Timeframe: 24 months

Rates of recurrent C. Diff infection defined by a positive molecular test for C. Diff and clinical symptoms.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=5 Participants Single arm Bezlotoxumab infusion
Number of Participants With Recurrent C. Diff Infection at 24 Months	0 Participants

SECONDARY outcome

Timeframe: 90 days

Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 90 days from receiving Bezlotuxumab.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=17 Participants Single arm Bezlotoxumab infusion
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days CRP	6 Participants
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days ESR	8 Participants

SECONDARY outcome

Timeframe: 12 months

Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 12 months from receiving Bezlotuxumab

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=8 Participants Single arm Bezlotoxumab infusion
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months CRP	0 Participants
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months ESR	0 Participants

SECONDARY outcome

Timeframe: 24 months

Rates of abnormal inflammatory markers C- Reactive protein (CRP) and Erythrocyte sedimentation rate (ESR) after 24 months from receiving Bezlotuxumab

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=5 Participants Single arm Bezlotoxumab infusion
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months CRP	1 Participants
Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months ESR	1 Participants

SECONDARY outcome

Timeframe: Index visit

Population: 14 CD, 5 UC

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.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=19 Participants Single arm Bezlotoxumab infusion
Quality of Life and Disease Activity Scores of Participants at Study Baseline SIBDQ	40.8 score on a scale Standard Deviation 14.02
Quality of Life and Disease Activity Scores of Participants at Study Baseline HBI	8.6 score on a scale Standard Deviation 5.2
Quality of Life and Disease Activity Scores of Participants at Study Baseline UCAI	6.2 score on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: 90 Days

Population: CD=12, UC=5

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.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=17 Participants Single arm Bezlotoxumab infusion
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days SIBDQ	40 score on a scale Standard Deviation 18.08
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
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 outcome

Timeframe: 12 months

Population: CD=7, UC=1

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.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=8 Participants Single arm Bezlotoxumab infusion
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months SIBDQ	49.75 score on a scale Standard Deviation 18
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
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months UCAI	3 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 24 months

Population: CD=4, UC=1

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.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=5 Participants Single arm Bezlotoxumab infusion
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
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months UCAI	0 score on a scale Standard Deviation 0
Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months SIBDQ	61.8 score on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 90 Days

Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 90 Days.

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=17 Participants Single arm Bezlotoxumab infusion
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days Hospital admissions	4 Ocurrences
Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days ED visits	10 Ocurrences

SECONDARY outcome

Timeframe: 12 months

Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 12 months

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=8 Participants Single arm Bezlotoxumab infusion
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months ED visits	6 Ocurrences
Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months Hospital admissions	2 Ocurrences

SECONDARY outcome

Timeframe: 24 months

Rates of ED visits and hospital admissions after Bezlotuxumab Infusion 24 months

Outcome measures

Outcome measures
Measure	Open Label Bezlotuxumab n=5 Participants Single arm Bezlotoxumab infusion
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months ED visits	1 Ocurrences
Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months Hospital admissions	2 Ocurrences

Adverse Events

Open Label Bezlotuxumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David G. Binion

University of Pittsburgh

Phone: 412-647-4194

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place