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 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT04218695
Eligibility Criteria:
Inclusion Criteria:
* MELD-Na \>= 18
* Cirrhosis as defined by liver biopsy or a composite assessment of available results from imaging, elastography, prior records, and laboratory studies
Exclusion Criteria:
* Inability to obtain consent (from subject or next of kin/legal authorized representative (LAR)
* Allergy to cephalosporins
* Pregnancy (due to limited prospective data regarding safety of ceftriaxone)
* Existing indication for new antibiotics, e.g. upper gastrointestinal hemorrhage or apparent infection
* Use of major immunosuppressive medications (e.g. prednisone 20 mg/day or greater, immunosuppression for solid organ transplant)
* H/o recurrent C difficile infection within the past year (\>2) or requiring fecal microbiota transplant (FMT)
* Enrollment in the study protocol during a previous admission
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04218695
Study Brief:
Protocol Section:
NCT04218695