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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT02692651
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years of age or older with \>3 unformed stools/24 hours with positive stool test for C. difficile.
* Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.
* High risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations
* Medium risk: 1st generation cephalosporin, macrolides\*, and aztreonam
* \*The macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection
Exclusion Criteria:
* Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).
* Patients with an allergy to oral vancomycin or fidaxomicin.
* Patients anticipated to receive metronidazole after enrollment.
* Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for \> 24 hours within the preceding 72 hours at the time of enrollment.
* Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.
* Patients who are on laxatives before they are enrolled into the study, such as lactulose, if:
* Patients have had a recent dose adjustment;
* Baseline number of bowel movement while on laxatives is unknown.
* Number of bowel movements and/or consistency has not changed from baseline.
* Patients who have had colostomy or ileostomy
* Patients who will have colostomy or ileostomy after enrollment and before study ends
* Patients who are or will be on long-term (\>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02692651
Study Brief:
Protocol Section:
NCT02692651