Trial Outcomes & Findings for Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics. (NCT NCT03937999)

NCT ID: NCT03937999

Last Updated: 2022-11-09

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 1 participants
• Primary outcome timeframe: within 4 weeks
• Results posted on: 2022-11-09

Participant Flow

Participant milestones

Measure	Bezlotoxumab Arm Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Bezlotoxumab: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.	No Bezlotoxumab Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) .
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.

Baseline characteristics by cohort

Measure	Bezlotoxumab Arm Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Bezlotoxumab: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.	No Bezlotoxumab n=1 Participants Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0).	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 4 weeks

Population: Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted.

Outcome measures

Measure	Bezlotoxumab Arm Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Bezlotoxumab: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.	No Bezlotoxumab n=1 Participants Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0).
Recurrence of C.Difficile Infection	—	0 Participants

SECONDARY outcome

Timeframe: within 8 weeks

Population: Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted.

Outcome measures

Measure	Bezlotoxumab Arm Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Bezlotoxumab: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.	No Bezlotoxumab n=1 Participants Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0).
Recurrence of C.Difficile Infection	—	0 Participants

SECONDARY outcome

Timeframe: within 8 weeks

Population: Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted.

Outcome measures

Measure	Bezlotoxumab Arm Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Bezlotoxumab: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.	No Bezlotoxumab n=1 Participants Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0).
Rate of Deaths	—	0 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted.

Outcome measures

Measure	Bezlotoxumab Arm Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 Bezlotoxumab: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.	No Bezlotoxumab n=1 Participants Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0).
Relapse of C. Difficile by 8 Weeks	—	1 Participants

Adverse Events

Bezlotoxumab Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Bezlotoxumab

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

Paul Riska, MD

Montefiore Medical Center

Phone: 718-920-6494

Email: priska@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place