Clinical trial NCT04626947: Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
Official title: Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Ulcerative Colitis
Crohn Disease
C. Diff. Infections
Keywords: C.diff
C. difficile
IBD
UC
Bezlotoxumab
Recurrent C. diff
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-11-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Recurrent C. Diff Infection at 90 Days
timeFrame: 90 days
measure: Number of Participants With Recurrent C. Diff Infection at 12 Months
timeFrame: 12 months
measure: Number of Participants With Recurrent C. Diff Infection at 24 Months
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 90 Days
timeFrame: 90 days
measure: Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 12 Months
timeFrame: 12 months
measure: Number of Participants With Positive Inflammatory Markers After Bezlotuxumab Infusion 24 Months
timeFrame: 24 months
measure: Quality of Life and Disease Activity Scores of Participants at Study Baseline
timeFrame: Index visit
measure: Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 90 Days
timeFrame: 90 Days
measure: Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 12 Months
timeFrame: 12 months
measure: Quality of Life and Disease Activity Scores of Participants After Bezlotuxumab Infusion 24 Months
timeFrame: 24 months
measure: Rates of Health Care Utilization After Bezlotuxumab Infusion 90 Days
timeFrame: 90 Days
measure: Rates of Health Care Utilization After Bezlotuxumab Infusion 12 Months
timeFrame: 12 months
measure: Rates of Health Care Utilization After Bezlotuxumab Infusion 24 Months
timeFrame: 24 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David Binion, MD
role: PRINCIPAL_INVESTIGATOR
References: