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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT02034851
Eligibility Criteria:
Inclusion Criteria:
Those children between 2 months and 14 years with a provable acute pyelonephritis that fulfill the hospitalization criteria defined in the Spanish Clinical practice guide. Briefly:
* age under 3 months.
* general affectation, toxic appearance.
* vomiting or oral intolerance.
* dehydration, bad peripheric perfusion.
* or other intermedia situations that include:
1. high fever (\>38.5 Celsius) in 3-6 month old children.
2. unusual germ risk factors.
3. family history of vesicoureteral reflux.
4. recurrent febrile urinary infections. With absence of a previous renal scarring objectivated after a DMSA.
5. high elevation of acute phase reactants.
Exclusion Criteria:
* those eligible patients that do not fulfill the hospitalization criteria.
* patients with a procalcitonin under 0.05 ng per ml.
* patients with previous uropathy or renal scarring
* patients allergic to dexamethasone.
* endocrinologic disease.
* history of cancer.
* serious illness.
* immunosuppressor treatment.
* previous treatment with corticoids (continuous oral or parenteral treatment) during the last 2 months.
* the patient included in the study that do not present pyelonephritis after the acute phase DMSA evaluation will be excluded.
* the patient included in the study that suffered a second pyelonephritis episode during the following 6 months (before the second DMSA evaluation) will be excluded for the primary output analyses.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
14 Years
Study:
NCT02034851
Study Brief:
Protocol Section:
NCT02034851