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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-12

Study Completion Date

2023-02-22

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.

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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.

Conditions

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Clostridium Difficile Infection Clostridium Difficile Infection Recurrence

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases

Patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment.

Bezlotoxumab

Intervention Type BIOLOGICAL

Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment

Controls

Patients who have received only standard CDI treatment.

Standard CDI treatment

Intervention Type DRUG

Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse

Interventions

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Bezlotoxumab

Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment

Intervention Type BIOLOGICAL

Standard CDI treatment

Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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