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 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT04979806
Eligibility Criteria:
Inclusion Criteria:
1. Male or female ≥ 18 years of age
2. Provide a signed written informed consent prior to any study-specific procedures
3. Meet the clinical criteria for either cUTI or AP
4. Requires hospitalization to manage the cUTI or AP
5. Agrees to use effective methods of contraception
Exclusion Criteria:
1. Known or suspected disease that may confound the assessment of efficacy.
2. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy.
3. Rapidly progressive illness such that the subject is unlikely to survive the study period.
4. Pregnant or breastfeeding women
5. History of a seizure disorder requiring current treatment
6. Creatinine clearance \< 15 mL/min or on renal dialysis
7. Neutropenia or elevated liver enzymes
8. Hypersensitivity to beta-lactam antibiotics
9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04979806
Study Brief:
Protocol Section:
NCT04979806