Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT02053350
Eligibility Criteria:
Inclusion Criteria:
* Adult of either gender, 18 years or older, with C. difficile infection (CDI)
* Diarrhea associated with C. difficile positive stool assay
* Within 48 hours of receiving either metronidazole for mild-moderate disease or vancomycin for severe uncomplicated disease
* Admitted in the hospital at the time of enrollment
* Ability to provide informed consent
* Have an understanding of study procedures
* Ability to comply with study procedures for the entire length of the study
Exclusion Criteria:
* Hypotension or shock
* Megacolon or moderate to severe ileus
* Acute abdomen
* Severe leukocytosis (WBC \> 20,000 cells /µL)
* Admission to intensive care unit on enrollment
* Inability to tolerate oral medication
* Other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
* Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis)
* Enrollment in another investigational drug trial
* Currently receiving other alternative treatment for CDI (e.g. antibiotics other than metronidazole or vancomycin; probiotics; immunoglobulin therapy; fecal transplant)
* Pregnancy
* Unavailable for follow-up visits
* Life expectancy of \< 6 months
* Chronic liver disease or in subjects without known liver disease, ALT \> 3x normal
* Chronic kidney disease or in subjects without known kidney disease, estimated Creatinine clearance of \< 30 ml/min, even after rehydration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02053350
Study Brief:
Protocol Section:
NCT02053350