Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

Study Overview
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Brief Summary
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This is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard C. difficile infection (CDI) treatment compared to standard CDI treatment alone in patients with CDI seen in an academic medical center's specialty outpatient clinic.

Detailed Description
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This specialty clinic is a unique practice setting where patients with ≥1 recurrent CDI and/or refractory disease are referred. The study will represent real-world data on the clinical use of bezlotoxumab as adjunctive therapy in combination with vancomycin or fidaxomicin for the treatment of patients with recurrent CDI. Retrospective chart review will be conducted for patients who visited the specialty CDI clinic between 1/1/2005 through 12/5/2019. Case patients will be defined as patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. Controls will be defined as patients who have received only standard CDI treatment and will be enrolled in a 2:1 ratio to cases. The primary outcome is recurrence of CDI. Recurrence is defined as a new episode of C. difficile infection that occurs after the initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or standard CDI treatment. Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy. Recurrent CDI will be diagnosed via clinical signs and symptoms and CDI diagnostic assay.

Official Title
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Real-world Evaluation of Bezlotoxumab for the Management of Clostridioides Difficile Infection

Conditions
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Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence

Intervention / Treatment
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* Biological: Bezlotoxumab
* Drug: Standard CDI treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Cases): Age 18 years and older Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay Received bezlotoxumab in addition to standard CDI treatment Inclusion Criteria (Controls): Age 18 years and older Diagnosis of C. difficile infection by clinical signs and symptoms and/or C. difficile diagnostic assay Received only standard CDI treatment Exclusion Criteria: Diarrhea due to causes other than C. difficile Incomplete documentation in the electronic medical record

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment. | Biological: Bezlotoxumab<br>* Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment<br>|
| Controls<br>Patients who have received only standard CDI treatment. | Drug: Standard CDI treatment<br>* Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CDI Recurrence | New episode of C. difficile infection that occurs after initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or completion of standard CDI treatment. | within 12 weeks of receipt of bezlotoxumab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure | Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy. | 2 consecutive days after completion of standard-of-care CDI therapy. |