A Phase 4 interventional study of Bezlotoxumab in Clostridium Difficile, sponsored by Montefiore Medical Center. Terminated at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Prevention
This study will examine whether the human monoclonal antibody, bezlotoxumab administered AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent antibiotic therapy, will eliminate the high risk of C. diff relapse.
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.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's enrollment of 1 is below the median of 65 across 233 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0
Drug: Bezlotoxumab
Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) .
Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
Also known as: Zinplava
Recurrence of C.Difficile Infection
Time frame: within 4 weeks
Recurrence of C.Difficile Infection
Time frame: within 8 weeks
Rate of Deaths
Time frame: within 8 weeks
Relapse of C. Difficile by 8 Weeks
Time frame: 8 weeks
| Milestone | Bezlotoxumab Arm | No Bezlotoxumab |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
| Participants | Bezlotoxumab Arm | No Bezlotoxumab |
|---|---|---|
| Recurrence of C.Difficile Infection | — | 0 |
| Participants | Bezlotoxumab Arm | No Bezlotoxumab |
|---|---|---|
| Recurrence of C.Difficile Infection | — | 0 |
| percentage of participants | Bezlotoxumab Arm | No Bezlotoxumab |
|---|---|---|
| Rate of Deaths | — | 0 |
| Participants | Bezlotoxumab Arm | No Bezlotoxumab |
|---|---|---|
| Relapse of C. Difficile by 8 Weeks | — | 1 |
Collected over Participants queried at 1 day, 4 weeks, and 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bezlotoxumab Arm | — | — | — |
| No Bezlotoxumab | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Only 1 participant was enrolled in the study (control group). Study terminated early due to lack of enrollment
| Age, Categorical(Participants) | Bezlotoxumab Arm | No Bezlotoxumab | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Bezlotoxumab Arm | No Bezlotoxumab | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Bezlotoxumab Arm | No Bezlotoxumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Bezlotoxumab Arm | No Bezlotoxumab | Total |
|---|---|---|---|
| United States | 0 | 1 | 1 |
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Plan to share: No
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