An observational study in Clostridium Difficile Infection and Clostridium Difficile Infection Recurrence, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by University of Illinois at Chicago · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 180 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Patients being treated for C. difficile infection
Inclusion Criteria (Cases):
Inclusion Criteria (Controls):
Exclusion Criteria:
Patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard CDI treatment.
Biological: Bezlotoxumab
Patients who have received only standard CDI treatment.
Drug: Standard CDI treatment
Bezlotoxumab 10 mg/kg IV infusion in addition to 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
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.
Time frame: within 12 weeks of receipt of bezlotoxumab
Clinical cure
Clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care CDI therapy.
Time frame: 2 consecutive days after completion of standard-of-care CDI therapy.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago