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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07484633
Eligibility Criteria:
Inclusion Criteria:
* paediatric patients (0-17 years of age) with suspected or confirmed bacterial infection who are treated in a PICU or NICU and diagnosed with sepsis with a total Phoenix Sepsis Score ≥2 points, and the infection is clinically probable or confirmed by microbiological culture (e.g. from a blood culture, cerebrospinal fluid, urine, trachea, wound, etc.), excluding contamination;
* who are receiving β-lactams including meropenem, piperacillin/tazobactam, cefepime and ceftriaxone;
* who received the same β-lactam therapy within 24 hours prior to inclusion or started new β-lactam therapy due to clinical deterioration;
* written consent of the parent or guardian is obtained.
Exclusion Criteria:
* palliative care patients;
* patients participating in other drug trials;
* patients with impaired renal function if dosing modification is required (eGFR\<50 mL/min/1.73m2 for meropenem, cefepime, and piperacillin/tazobactam; eGFR\<10 mL/min/1.73m2 for ceftriaxone);
* patients undergoing plasmapheresis (TPE);
* patients undergoing extracorporeal therapy (continuous kidney replacement therapy \[CKRT\] or extracorporeal membrane oxygenation \[ECMO\]);
* β-lactam allergy;
* patients admitted from another institution or department who have been on the same β-lactam treatment for more than 24 hours;
* pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
17 Years
Study:
NCT07484633
Study Brief:
Protocol Section:
NCT07484633