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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT02254967
Eligibility Criteria:
Inclusion Criteria:
* CDI is confirmed by clinical symptoms (either \> 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
* Subject agrees not to participate in another interventional study whilst participating in this study.
Exclusion Criteria:
* Subject is taking or requiring to be treated with prohibited medications
* Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
* Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
* Subject is unable to swallow oral study medication.
* Subject has a current diagnosis of toxic megacolon.
* Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
* Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
* Subject has previously participated in a CDI vaccine study
* Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02254967
Study Brief:
Protocol Section:
NCT02254967