Acute pyelonephritis
Conditions
Interventions
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
Sponsors
Unitat de Recerca en Pediatria Nutrició i Desenvolupament Humà
Eligibility
Sex/Gender
All
Inclusion criteria
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 endovenous treatment. Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Children with acute pyelonephritis between 2 months and 14 years who do not meet the criteria for hospitalization, b) Patients with procalcitonine < 0.05 ng/ml, c) Patients with previous renal scarring or previous uropathy, d) Patients with previous acute pyelonephritis if there is no confirmation by DMSA that renal sacrring is absent, e) Patinets with dexametasona alergy, f) Endocrinologis diseases (suprarenal insuficiency, bad controled DM), g) Previous history of cancer, h) Patients with severe disease, i) Patients with immunosupresor treatment, j) Previous oral or parenteral corticoid treatment within the last 2 monts, k) Those patients that have been vaccinated with live vaccine during the two weeks before the start of the trial intervention, l) Those patients included in the study who develope a second urinary tract infection within the 6 monts of follow up will be excluded. m) Acute renal damage absence in the ealry DMSA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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).;Primary end point(s): Percentatge reduction inthe risk of renal scarring after an acute pyelonephritis episode by dexamethasone treatment added to the conventional therapy.;Timepoint(s) of evaluation of this end point: Six months after acute pyelonephritis diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Spain
Contacts
Public ContactUnitat de Recerca en Pediatria Nutr
Unitat de Recerca en Pediatria Nutrició i Desenvolupament Humà
Outcome results
None listed