NCT04317963

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Clostridium Difficile Infection
• Clostridium Difficile Infection Recurrence

Interventions

Type	Name	Description
BIOLOGICAL	Bezlotoxumab	Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment
DRUG	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

Timeline

• Start date: 2020-02-12
• Primary completion: 2023-02-22
• Completion: 2023-02-22
• First posted: 2020-03-23
• Last updated: 2023-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study