Phase
Condition
N/ATreatment
REC-3964
Clinical Study ID
Ages 18-115 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrheaassociated with a positive stool test for C. difficile toxin[s] prior to thepreceding curative treatment.
The CDI episode, severe or otherwise, must have resolved after receiving vancomycinwith a standard duration of treatment. The participant must be randomized within 2days of completing the preceding curative treatment.
Have high risk for rCDI (a recurrent CDI episode within the last 6 months, age ≥65years, immunocompromised state, or severe CDI with resolution prior to enrollmentinto the study).
Exclusion
Key Exclusion Criteria:
Have an active, symptomatic, chronic diarrheal illness from other causes, such asulcerative colitis or Crohn's disease.
Diarrhea that requires on-study treatment with agents that would confound theinterpretation of the study results.
Study Design
Study Description
Connect with a study center
Northern Arizona Healthcare - Flagstaff Medical Center
Flagstaff, Arizona 86001
United StatesSite Not Available
Nod MD
Phoenix, Arizona 85022
United StatesSite Not Available
Lawrence J. Ellison Ambulatory Care Center
Sacramento, California 95817
United StatesSite Not Available
Emory University Hospital Midtown
Atlanta, Georgia 30365
United StatesSite Not Available
Snake River Research
Idaho Falls, Idaho 83404
United StatesSite Not Available
Washington University School of Medicine - Division of Infectious Diseases
St. Louis, Missouri 63110
United StatesSite Not Available
GANJ - Toms River - Ocean Family Gastroenterology
Toms River, New Jersey 08755
United StatesSite Not Available
Montefiore Medical Group - Family Care Center (FCC)
Bronx, New York 10467
United StatesSite Not Available
Frontier Clinical Research
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Southern Star Research Institute, LLC
San Antonio, Texas 78229
United StatesSite Not Available
University of Utah Medical Center
Salt Lake City, Utah 84132
United StatesSite Not Available
Medical Associates of Central Virginia
Lynchburg, Virginia 24501
United StatesSite Not Available
University of Wisconsin - Madison
Madison, Wisconsin 53705
United StatesSite Not Available
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