Evaluation of the Plasmatic NGAL as a Predictive Marker of Renal Injury in Children With Urinary Infection. (Perf-NGAL-IU)
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      Urinary infections in children is very common. Delay in the diagnosis may be followed by
      complications.

      Pyelonephritis is a febrile urinary infection with a renal injury. In local experience, about
      30-40% of the children don't have an inflammatory syndrome or echographical abnormalities. Do
      they really have a renal injury ? In fact, only the scintigraphy or the Magnetic Resonance
      Imaging (MRI) may show these lesions, but are done only in specific cases (diagnosis of
      uropathy or nephropathy). Recent studies have shown that plasmatic Neutrophil
      Gelatinase-Associated Lipocalin (NGAL) is associated traumatic or inflammatory renal lesions.
      But the plasmatic NGAL cutoff is fluctuant depending on the cohorts and gold standards. The
      main goal is to evaluate a new methodology of dosing NGAL, (immuno-dosage turbidimetric
      dosage). The investigators suppose that plasmatic NGAL protein will detect renal injury,
      which would be confirmed by MRI.

      The aim of this study is to evaluate the area under the curve (AUC) of plasmatic NGAL protein
      with an automatised method, for the detection of renal injury. This would be confirmed by
      reno vesical MRI, in children over 2 years old with febrile urinary infections
    

Detailed description: 
      Urinary infections in children is very common and should be diagnosed as soon as possible.
      Delay in the diagnosis ma be followed by complications such as sepsis, renal scar, high blood
      pressure, renal insufficiency.

      The diagnosis may be tough when it comes to children because of its unspecific
      symptomatology. Pyelonephritis is a febrile urinary infection associated to renal
      abnormalities. Following the french recommendations ("Sociéte de Pathologie Infectieuse de
      Langue Française" The French Society of Infectious disease SPILF and "Groupe de Pathologies
      Infectieuses Pédiatriques" The Pediatric infectious disease Group GPIP 2015), the
      investigators should first use an intravenous probabilistic antibiotic during minimum 48
      hours to lower the bacterial inoculum. Then, the investigators should switch to an oral
      antibiotic during 8 days to sterilise the urines.

      In local experience, about 30 to 40 % of the children don't have an inflammatory syndrom or
      echographical abnormalities. Do they really have a renal injury? In fact, only the
      scintigraphy or the Magnetic Resonance Imaging (MRI) may show these lesions, but are done
      only in specific cases (diagnosis of uropathy or nephropathy). Recent studies have shown that
      plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) is associated traumatic or
      inflammatory renal lesions. But the plasmatic NGAL cutoff is fluctuant depending on the
      cohorts and gold standards. In those studies, dosing NGAL was non automatised and long.

      the investigators would like to evaluate a new methodology of dosing NGAL, (immuno-dosage
      turbidimetric dosage). The investigators suppose that plasmatic NGAL protein will detect
      renal injury, which would be confirmed by MRI.

      This is an interventional, prospective, multicentered study. It will last for 2 years. The
      aim of this study is to evaluate the AUC of plasmatic NGAL protein with an automatised
      method, for the detection of renal injury. This would be confirmed by reno vesical MRI, in
      children over 2 years old with febrile urinary infections.
    

Intervention name(s): plasmatic NGAl and MRI
Intervention type(s): Diagnostic Test
Intervention description(s): Determination of plasma NGAL protein during routine blood test Realization of a reno vesical MRI at 48 hours of inclusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic