Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
|ClinicalTrials.gov Identifier: NCT03937999|
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and expected to resume. This is not a suspension of IRB approval)
First Posted : May 6, 2019
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile||Drug: Bezlotoxumab||Phase 4|
Clostridioides difficile (C. diff) is a germ (bacteria) that causes life-threatening diarrhea. It is usually a side-effect of taking antibiotics that affect the normal balance of bacteria in the intestines. When the "good bacteria" in the intestine are killed by antibiotics, the C.diff bacteria begin to grow and produce toxins, causing frequent diarrhea and other symptoms such as abdominal pain or tenderness, loss of appetite, low-grade fever, nausea and vomiting. C. diff can be treated by using special antibiotics, but it tends to come back in about 20% of patients. C-diff is problematic because of frequent relapses after apparent cure. The greatest risk factor for relapse is receipt of subsequent antibiotics, in the hospital, shortly after being treated.
Zinplava™(bezlotoxumab) is an FDA approved human monoclonal antibody designed to prevent the recurrence of C.diff.This is not an antibiotic, as it does not kill C. diff, but is an antibody to C. diff toxins, which stops the damage. When Bezlotoxumab is given during a C. diff infection together with antibiotics to kill C. diff, it decreases the risk that C. diff will come back by about one-half. Bezlotoxumab is approved for use when given during a C. diff infection, but it has not been used to prevent C diff in other situations, such as the one being studied in this research.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intervention group compared to concurrent and historical control groups|
|Masking:||None (Open Label)|
|Official Title:||A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.|
|Actual Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||May 15, 2021|
Experimental: Bezlotoxumab Arm
Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0
Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
Other Name: Zinplava
No Intervention: No Bezlotoxumab
Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) .
- Recurrence of C.diff infection [ Time Frame: within 4 weeks ]
- Recurrence of C. diff infection [ Time Frame: within 8 weeks ]
- Rate of deaths [ Time Frame: within 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937999
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Paul Riska, MD||Montefiore Medical Center|