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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04317963
Other study ID # 2019-1381
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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