Dexamethasone Administration in 1st Episode of Febrile Urinary Tract Infection
Condition: Acute Pyelonephritis
MeSH terms: Urinary Tract Infections; Pyelonephritis
Study type: Observational [Patient Registry]

Summary: 
      Hypothesis: Administration of corticoids (dexamethasone) together with the conventional
      antibiotherapy in the acute phase of a febrile urinary tract infection could reduce the risk
      of renal scarring after 6 months of the primo-infection.

      Primary objectives:To evaluate the reduction in incidence of renal scarring after 6 months of
      a acute pyelonephritis between the control group (conventional therapy plus placebo) and
      intervention group (conventional therapy plus dexamethasone.

      Design: Multicentre randomized clinical trial,placebo controled, including children between 2
      months and 14 years with a acute pyelonephritis proven by a acute phase DMSA
      (dimethylsuccinic acid ). A total of 180 children in to parallel groups (intervention and
      placebo) will be included.
    

Detailed description: 
      The urinary tract infection (UTI) is one of the most common bacterial infections in children.
      These infections can be grouped clinically as asymptomatic bacteriuria , cystitis (lower
      urinary tract infection ) and acute pyelonephritis (APN ) when the infection reaches the
      upper urinary tract. This classification is of great clinical relevance because while
      cystitis is usually a benign condition without further complications , the APN is associated
      with an increased risk of kidney damage, acquired through renal scarring . Renal scarring is
      a consequence of the inflammatory and immune response that is triggered to eradicate the
      bacteria involved in the UTI. Parenchymal infection can be solved , but there are a number of
      poorly understood factors that may perpetuate inflammation and this would promote the
      formation of scar nephritis. One of the most relevant factors involved in the renal scarring
      development are the production of inflammatory mediators (complement proteins, bactericidal
      peptides, cytokines such as IL6 and IL8, chemokines, and adhesion molecules defensins). Thus,
      it is obvious to think that the use of anti-inflammatory drugs may prevent the release of
      these mediators and the development of permanent kidney damage.

      Intervention: the two parallel groups will receive the conventional therapy plus:

        1. dexamethasone: 0'30 mg per kg every 12 hours during 3 days.

        2. placebo (physiological saline)at the same dosing regimen.

      Centralized lecture of the late DMSA after 6 months of the pyelonephritis episode will be
      performed. Renal scarring presence and grade will be reported.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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.
      
Keywords: Acute pyelonephritis; Renal scarring; Dexamethasone; Children; Corticoids; Complementary treatment; Prevention strategy