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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT05320068
Eligibility Criteria:
Inclusion Criteria:
* Age equal or superior to 18 years
* Previous history of Clostridioides difficile infection in the 90 days before the study enrolment
* Need for hospitalization and need of antibiotic therapy
* Signature of informed consent
Exclusion Criteria:
* Woman of childbearing age, pregnant woman, or breastfeeding woman
* Hypersensitivity to vancomycin
* Inability to comply with study protocol
* Critically ill condition or life expectancy less than 30 days
* Patients with diagnosed inflammatory bowel disease or with any conditions that produce chronic diarrhea
* Fulfilment of the criteria for diarrhea or diagnosis of CDI at the time of assessment for eligibility or in the previous 3 days
* Therapy with oral vancomycin or any other agent with activity against C. difficile for \>48 hours in the previous 3 days;.
* Prophylaxis with oral vancomycin or any other agent with activity against C. difficile within the 70 days before the assessment for eligibility
* Systemic antibiotic therapy for 72 hours or more before the recruitment
* Ongoing enrolment in another RCT evaluating the effectiveness of other drugs
* Estimated use of systemic antibiotic therapy for more than 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05320068
Study Brief:
Protocol Section:
NCT05320068