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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT03721302
Eligibility Criteria:
Inclusion Criteria:
* In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions
* Age \<60 days of age
* Clinical suspicion of a new episode of sepsis (as defined below)\*\* together with planned treatment with IV antibiotics OR new episode of confirmed bacterial meningitis\^ OR new episode of infection in which a Carbapenem-resistant organism (CRO) is isolated from blood culture OR new episode of infection in which a candida species is isolated from blood culture
* Informed consent from parent / guardian
* Willingness to provide location information and to be contacted at 28 days from start of antibiotic treatment
Exclusion Criteria:
* • Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached
* Enrollment in any interventional trial
* A serious, non-infective co-morbidity (other than prematurity), anticipated to cause death within 72 hours
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
60 Days
Study:
NCT03721302
Study Brief:
Protocol Section:
NCT03721302