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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT02563106
Eligibility Criteria:
Inclusion Criteria:
* Expected minimum hospital stay of 5 days
* Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide
* Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive infiltrate on chest x-ray is recommended.
Exclusion Criteria:
* Presence of a diarrheal illness within 72 hours prior to randomization
* Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool
* Number of previous CDAD episodes \>1 within 12 weeks of randomization and no C. difficile infection (CDI) within 4 weeks of randomization
* Use of antibiotics within 1 month of start of study drug except for the current illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02563106
Study Brief:
Protocol Section:
NCT02563106