Trial Outcomes & Findings for Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery. (NCT NCT03756454)
NCT ID: NCT03756454
Last Updated: 2026-06-18
Results Overview
Monitor for 30-day mortality
TERMINATED
PHASE4
5 participants
30-days
2026-06-18
Participant Flow
1 subject not randomized/dosed
Participant milestones
| Measure |
Bezlotoxumab
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Effectiveness of IV Bezlotoxumab Versus Placebo in Decreasing Morbidity and Mortality in Patients With Fulminant C. Diff Requiring Surgery.
Baseline characteristics by cohort
| Measure |
Bezlotoxumab
n=2 Participants
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
n=2 Participants
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
50.5 years
n=20 Participants
|
48 years
n=20 Participants
|
49.25 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=20 Participants
|
2 participants
n=20 Participants
|
4 participants
n=40 Participants
|
|
Heart Failure prior to enrollment
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Respiratory Failure prior to enrollment
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Renal Failure prior to enrollment
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Hepatic Failure prior to enrollment
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 30-daysPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Monitor for 30-day mortality
Outcome measures
| Measure |
Bezlotoxumab
n=2 Participants
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
n=2 Participants
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
|---|---|---|
|
Mortality
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30-daysPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Monitor for development of heart failure
Outcome measures
| Measure |
Bezlotoxumab
n=2 Participants
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
n=2 Participants
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
|---|---|---|
|
Heart Failure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30-daysPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Monitor for development of respiratory failure
Outcome measures
| Measure |
Bezlotoxumab
n=2 Participants
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
n=2 Participants
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
|---|---|---|
|
Respiratory Failure
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30-daysPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Monitor for development of renal failure
Outcome measures
| Measure |
Bezlotoxumab
n=2 Participants
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
n=2 Participants
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
|---|---|---|
|
Renal Failure
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30-daysPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Monitor for development of hepatic failure
Outcome measures
| Measure |
Bezlotoxumab
n=2 Participants
Patients receiving Bezlotoxumab post-operatively.
Bezlotoxumab: Patients receiving Bezlotoxumab post-operatively.
|
Normal Saline
n=2 Participants
Patients receiving normal saline as a placebo post-operatively.
Normal Saline: Placebo
|
|---|---|---|
|
Hepatic Failure
|
0 Participants
|
1 Participants
|
Adverse Events
Bezlotoxumab
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jon Wisler
The Ohio state University Wexner Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place