Dexametasona administration in first febrile urinary tract infection episode as renal damage

INTERVENTION: Trade Name: FORTECORTIN 4 MG SOLUCION INYECTABLE Product Name: FORTECORTIN 4 MG SOLUCION INYECTABLE Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE CAS Number: 2392‐39‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Acute pyelonephritis Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective: To evaluate the reduction in percentage of renal scarring presence between control group (conventional therapy) and intervention group (conventional therapy + dexametasona) after 6 months of infectious episode diagnosis Primary end point(s): Percentatge reduction inthe risk of renal scarring after an acute pyelonephritis episode by dexamethasone treatment added to the conventional therapy. Secondary Objective: To evaluate diferences in:; ‐ clinical variables (hospitalization time, fever hours, recurrence % within 6 months after diagnosis); ‐ inflamatory variables (urinary IL6 and IL8, serum procalcitonin and CRP at admision); ‐ radiologic variables (determined by DMSA after 6 months of diagnosis); ; between control and intervention group.; ; ‐ To determine predictive factors for permanent renal damage.; ‐ To evaluate the intervention effect on high riks subgroups (i.e. vesiculouretral reflux). Timepoint(s) of evaluation of this end point: Six months after acute pyelonephritis diagnosis SECONDARY OUTCOME: Secondary end point(s): Diferences between control group and intervention group in:; ‐ days of hospitalizacion,; ‐ fever hours,; ‐ urine IL6 and IL8 concentration,; ‐ blood PCT and PCR confentration at admision. Timepoint(s) of evaluation of this end point: During hospitalization. INCLUSION CRITERIA: Children with suspected acute pyelonephritis (aged between 2 months abd 14 years) confirmed by acute phase DMSA who meet the criteria for hospitalization defined in the Clinical Practice Guidances for urinary tract infection in pediatric population (Plan de Calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Política Social e Igualdad. Instituto Aragonés de Ciencias de la Salud; 2011). In brief: a) age less than 3 months, b) General condition afectation, toxic appearance, c) Vomiting, oral intolerance, d) Deshidratation, bad peripheral perfusion, e) Intermedium risk situations as: ‐ High fever (more than 38.5ºC) in 3‐6 month infabts and fever persistence after 48h of treatment, ‐ Inusual germ risk factors (recent antibiotherapy or hospitalization, cateterism), ‐ Family history of vesiculouretral reflux, repetitive febrile urinary infections, ‐ Significant elevation of acute phase reactants that could require end