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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04642560
Eligibility Criteria:
Inclusion Criteria:
* Neonates, infants and children hospitalized in Pediatric or Neonatal ICU and receiving systemic (intravascular, intramuscular or oral) antibiotic treatment for less than 24 hours with appropriate dosages for an episode of suspected or proven community-acquired or nosocomial bacterial infection.
* Informed verbal consent obtained from both parents or legal guardians.
Exclusion Criteria:
* Newborns \<72 hours old.
* Neonates \<37 weeks of corrected gestational age.
* Age ≥18 years.
* Antibiotic prophylaxis.
* Children previously included in an interventional study in progress.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
72 Hours
Maximum Age:
17 Years
Study:
NCT04642560
Study Brief:
Protocol Section:
NCT04642560