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 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT00873327
Eligibility Criteria:
Inclusion Criteria:
1. Written permission from parent or legal guardian
2. \< 61 days of age
3. Likely to survive beyond the first 48 hours after enrollment
4. Sufficient intravascular access (either peripheral or central) to receive study drug.
AND ONE OF THE FOLLOWING
1. Suspected systemic infection
2. Receiving piperacillin-tazobactam as part of standard of care
Exclusion Criteria:
1. History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
2. Urine output \< 0.5 mL/hr/kg over the prior 24 hours
3. Serum creatinine \> 1.2 mg/dL
4. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Days
Study:
NCT00873327
Study Brief:
Protocol Section:
NCT00873327