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

NCT04317963 | Completed FDA Drug

• 1 other identifier: 2019-1381
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile Infection; Clostridium Difficile Infection Recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical cure

  2 consecutive days after completion of standard-of-care CDI therapy.

Study Arms (2)

Cases

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

Biological: Bezlotoxumab

Controls

Patients who have received only standard CDI treatment.

Drug: Standard CDI treatment

Interventions

Bezlotoxumab BIOLOGICAL

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

Cases

Standard CDI treatment 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

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being treated for C. difficile infection

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

bezlotoxumab

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Eric R Wenzler, PharmD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pharmacy Practice

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: February 12, 2020
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

US (1)