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

Clostridium Difficile Infection Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04317963
Study type Observational
Source University of Illinois at Chicago
Contact
Status Completed
Phase
Start date February 12, 2020
Completion date February 22, 2023
View Details
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