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

Completed

• Conditions: Clostridium Difficile Infection Recurrence; Clostridium Difficile Infection
• Interventions: Drug: Standard CDI treatment; Biological: Bezlotoxumab

• Registration Number: NCT04317963
• Lead Sponsor: University of Illinois at Chicago

Brief 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.

Study Timeline

• Study Start: 2020-02-12
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-23
• Status Verified: 2023-02
• Primary Completion: 2023-02-22
• Study Completion: 2023-02-22
• Last Update Submitted: 2023-02-26
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

• Diarrhea due to causes other than C. difficile
• Incomplete documentation in the electronic medical record

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Standard CDI treatment	Patients who have received only standard CDI treatment.
Cases	Bezlotoxumab	Patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment.

Primary Outcome Measures

Name	Time	Method
Rate of CDI Recurrence	within 12 weeks of receipt of bezlotoxumab	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.

Secondary Outcome Measures

Name	Time	Method
Clinical cure	2 consecutive days after completion of standard-of-care CDI therapy.	Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy.

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States