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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT07070102
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 0 to 15 years
* Presenting with a febrile urinary tract infection due to GNR (a febrile urinary tract infection is defined as a urine culture showing significant leukocyturia (≥104) and direct examination showing GNR, in a patient with fever)
* Requiring hospitalization in the general pediatrics, emergency (short-stay hospitalization unit), nephrology, or intensive care units of the Robert-Debré University Hospital for a presumed period of at least 48 hours.
* Non-opposition of the legal representatives obtained by one of the investigator
Exclusion Criteria:
* Presence of sepsis (Phoenix score ≥ 2)
* Gram-positive cocci (GPC) urinary tract infection (Urinalysis before antibiotic therapy revealed significant leukocyturia (≥104) and direct examination revealed GPC)
* Known allergy to beta-lactam antibiotics
* Severe renal impairment (glomerular filtration rate \<30 mL/min\*1.73 m2)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
15 Years
Study:
NCT07070102
Study Brief:
Protocol Section:
NCT07070102