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Slow enrollment due to COVID19 , change in practice with standardized use of oral vancomycin prophylaxis
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bezlotoxumab Arm | Experimental | Single dose of Bezlotoxumab 10mg/kg iv over 60 minutes on Day 0 |
|
| No Bezlotoxumab | No Intervention | Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bezlotoxumab | Drug | Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of C.Difficile Infection | within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of C.Difficile Infection | within 8 weeks | |
| Rate of Deaths | within 8 weeks | |
| Relapse of C. Difficile by 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Riska, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | No Bezlotoxumab | Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0) . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only 1 participant was enrolled in the study (control group). Study terminated early due to lack of enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No Bezlotoxumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence of C.Difficile Infection | Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted. | Posted | Count of Participants | Participants | within 4 weeks |
|
Participants queried at 1 day, 4 weeks, and 8 weeks
No participants were enrolled into the treatment into the Bezlotoxumab Arm of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Riska, MD | Montefiore Medical Center | 718-920-6494 | priska@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2020 | Sep 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000613978 | bezlotoxumab |
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Intervention group compared to concurrent and historical control groups
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| 8 weeks |
Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Recurrence of C.Difficile Infection | Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted. | Posted | Count of Participants | Participants | within 8 weeks |
|
|
|
| Secondary | Rate of Deaths | Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted. | Posted | Number | percentage of participants | within 8 weeks |
|
|
|
| Secondary | Relapse of C. Difficile by 8 Weeks | Only 1 participant was enrolled in the study (into the 'No Bezlotoxumab' control group). No statistical analysis was conducted. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Bezlotoxumab | Control group who are eligible as per the inclusion/exclusion criteria to the Bezlotoxumab arm, but not given Bezlotoxumab (Day 0). | 0 | 1 | 0 | 1 | 0 | 1 |
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