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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT01391793
Eligibility Criteria:
Inclusion Criteria:
* Age: 2 months to 6 years
* Pyuria: ≥10 white blood cells per cubic millimeter (WBC/mm3) in an uncentrifuged specimen or ≥5 white blood cells per high power field (WBC/hpf) in a centrifuged specimen or ≥1+ leukocyte esterase (LE) on dipstick
* Fever: documented temperature of at least 101 °F or 38.3°C, measured anywhere on the body either at home or at doctor's office within 24 hours of diagnosis
Exclusion Criteria:
* Other concurrent systemic bacterial infection(s) such as meningitis or pneumonia;
* Planned admission to intensive care unit;
* Known bacteremia;
* Previous protocol defined UTI;
* Known major urinary tract anomalies (severe hydronephrosis, ureterocele, urethral valve, solitary or profoundly small kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic or fused kidney);
* Congenital/acquired immunodeficiency;
* Bag urine collection
* Chronic diseases that could potentially interfere with response to therapy, such as chronic gastrointestinal conditions (i.e. malabsorption, inflammatory bowel disease), liver/kidney failure;
* Allergy to dexamethasone
* Antibiotic use within 7 days of enrollment (except if given in the last 48 hours)
* Systemic use of corticosteroids or other immunomodulating agents within 14 days of enrollment
* History of Kawasaki disease
* Sickle cell disease (not trait)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
6 Years
Study:
NCT01391793
Study Brief:
Protocol Section:
NCT01391793