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 Details — Status: Completed

Administrative data

• NCT number: NCT04317963
• Other study ID #: 2019-1381
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: February 22, 2023

Study information

• Verified date: February 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 22, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Difficile Infection Recurrence
• Clostridium Infections
• Communicable Diseases
• Infections
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.