Evaluation of the Plasmatic NGAL as a Predictive Marker of Renal Injury in Children With Urinary Infection. (Perf-NGAL-IU)

NCT04191785 | Completed

• 1 other identifier: 18-HPNCL-08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Compare plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) with gold standard Reno vesical Magnetic Resonance Imaging (MRI)

  NGAL will be evaluated in urines, and plasma. The method will be automatised. The dosage will be from 25 to 5000 ng/ml. Gold standard will be MRI (nephritis is defined by hyperintense zones in diffusion sequence and hyposignal in ADC mode) The primary outcome measure is to estimate the area under the curve (AUC) defining the different measures of the performance (Sensitivity, specificity) of plasmatic NGAL protein in ng/ml according to the presence or not of a kidney lesion diagnosed at the RMI (gold standard).

  48 hours after inclusion

Secondary Outcomes (7)

• Define performance of plasmatic NGAL for the diagnostic of renal abnormality due to a pyelonephritis

  48 hours after inclusion

• Performance and area under the curve (AUC) of C-reactive Protein (CRP) for the diagnostic of pyelonephritis

  48 hours after inclusion

• Performance and area under the curve (AUC) of Procalcitonin (PCT) for the diagnostic of pyelonephritis

  48 hours after inclusion

• Compare the AUC of plasmatic NGAL and CRP

  48 hours after inclusion

• Compare the AUC of plasmatic NGAL and PCT.

  48 hours after inclusion

Study Arms (1)

plasmatic NGAL and MRI

EXPERIMENTAL

Diagnostic Test: plasmatic NGAl and MRI

Interventions

plasmatic NGAl and MRI DIAGNOSTIC_TEST

Determination of plasma NGAL protein during routine blood test Realization of a reno vesical MRI at 48 hours of inclusion

plasmatic NGAL and MRI

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children over 4 years old, continent
• Fever ≥ 38,5 degrés Celsius for less than 4 days
• Positive urine strip
• Parental authorisation
• Using french Health Care System

You may not qualify if:

• Uropathy
• nd febrile urinary infection
• No parental authorisation
• Non confirmed Urinary infection on a well done Cyto Bacteriological Urine (CBU)
• Urinal contamination defined by : ≥ 2 bacterial, urinal bacteriuria \< 10\^5 Colony Forming Unit (CFU)/ml

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval

Nice, France

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Tran Antoine, MD

  Children Hopital of Nice CHU-Lenval Emergency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: December 10, 2019
• Study Start: March 11, 2020
• Primary Completion: April 20, 2023
• Study Completion: October 26, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

FR (1)