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OpenTrials
Completed

NCT Number: NCT04317963

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

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.

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Key information

Conditions

Clostridium Difficile Infection Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Infection Recurrence Clostridium Infections Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bezlotoxumab

Biological

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

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

Primary outcomes

  1. Rate of CDI Recurrence

    Time frame: 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 outcomes

  1. Clinical cure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2020
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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