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 @ 10:31 PM
Ignite Modification Date:
2025-12-24 @ 10:31 PM
NCT ID:
NCT06462235
Eligibility Criteria:
Inclusion Criteria
Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:
1. Hospitalized with age from birth \<9 months, including preterm birth
2. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
3. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
Participants with any of the following characteristics/conditions will be excluded:
1. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
2. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
3. Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output \<0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis.
4. Part B Only: Received \>24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom of infection after ≥48 hours of antibiotics.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
39 Weeks
Study:
NCT06462235
Study Brief:
Protocol Section:
NCT06462235