NCT04317963

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

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT04317963

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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.

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

Disease(s) and\or Condition(s)

Clostridium Difficile Infection

Clostridium Difficile Infection Recurrence

Primary Purpose

Intervention/Treatment

- Type: BIOLOGICAL
- Name: Bezlotoxumab
- Description: Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment
- Arm Group Labels: Cases
- Type: DRUG
- Name: Standard CDI treatment
- Description: Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse
- Arm Group Labels: Controls

Sponsor

University of Illinois at Chicago