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

Primary Purpose

Urinary Tract Infections

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
plasmatic NGAl and MRI
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Uropathy
  • 2nd 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

Sites / Locations

  • Hôpital La FontonneRecruiting
  • Fondation Lenval Hopitaux Pediatriques de Nice Chu LenvalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

plasmatic NGAL and MRI

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Define performance of plasmatic NGAL for the diagnostic of renal abnormality due to a pyelonephritis
The performance of NGAL will be evaluated (sensitivity, specificity, positive predictive value, negative predictive value) using the chosen cutoff of NGAL. Gold standard will be reno vesical MRI
Performance and area under the curve (AUC) of C-reactive Protein (CRP) for the diagnostic of pyelonephritis
The performance (sensitivity, specificity, positive predictive value, negative predictive value) and the AUC of CRP will be defined using the following cutoff (CRP > 20 mg/l ) chosen from the litterature. CRP will be dosed by an automatised method on XL Siemens machine.
Performance and area under the curve (AUC) of Procalcitonin (PCT) for the diagnostic of pyelonephritis
The performance (sensitivity, specificity, positive predictive value, negative predictive value) and the AUC of PCT will be defined using the following cutoff ( PCT > 0,5 ng/ml) chosen from the litterature. PCT will be dosed using a Brahms automat
Compare the AUC of plasmatic NGAL and CRP
AUC for plasmatic NGAL will be compared to AUC of CRP, AUC will be calculated using receiver operator characteristic (ROC) curves
Compare the AUC of plasmatic NGAL and PCT.
AUC for plasmatic NGAL will be compared to AUC of PCT. AUC will be calculated using receiver operator characteristic (ROC) curves
Performance of urinary NGAL
Define an area under receiver operator characteristic (ROC) curve based on the dosage of urinary NGAL used to diagnose renal abnormality. 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 Apparent Diffusion coefficient (ADC) mode).
Performance of doppler echography
The performance of doppler echography (sensitivity, specificity, positive predictive value, negative predictive value) will be established using MRI as a gold standard.

Full Information

First Posted
August 27, 2019
Last Updated
May 5, 2023
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT04191785
Brief Title
Evaluation of the Plasmatic NGAL as a Predictive Marker of Renal Injury in Children With Urinary Infection. (Perf-NGAL-IU)
Acronym
Perf-NGAL-IU
Official Title
Evaluation of the Plasmatic and Urinary Neutrophil Gelatinase - Associated Lipocalin as a Predictive Marker of Renal Injury in Children With Febrile Urinary Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
plasmatic NGAL and MRI
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
plasmatic NGAl and MRI
Intervention Description
Determination of plasma NGAL protein during routine blood test Realization of a reno vesical MRI at 48 hours of inclusion
Primary Outcome Measure Information:
Title
Compare plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) with gold standard Reno vesical Magnetic Resonance Imaging (MRI)
Description
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).
Time Frame
48 hours after inclusion
Secondary Outcome Measure Information:
Title
Define performance of plasmatic NGAL for the diagnostic of renal abnormality due to a pyelonephritis
Description
The performance of NGAL will be evaluated (sensitivity, specificity, positive predictive value, negative predictive value) using the chosen cutoff of NGAL. Gold standard will be reno vesical MRI
Time Frame
48 hours after inclusion
Title
Performance and area under the curve (AUC) of C-reactive Protein (CRP) for the diagnostic of pyelonephritis
Description
The performance (sensitivity, specificity, positive predictive value, negative predictive value) and the AUC of CRP will be defined using the following cutoff (CRP > 20 mg/l ) chosen from the litterature. CRP will be dosed by an automatised method on XL Siemens machine.
Time Frame
48 hours after inclusion
Title
Performance and area under the curve (AUC) of Procalcitonin (PCT) for the diagnostic of pyelonephritis
Description
The performance (sensitivity, specificity, positive predictive value, negative predictive value) and the AUC of PCT will be defined using the following cutoff ( PCT > 0,5 ng/ml) chosen from the litterature. PCT will be dosed using a Brahms automat
Time Frame
48 hours after inclusion
Title
Compare the AUC of plasmatic NGAL and CRP
Description
AUC for plasmatic NGAL will be compared to AUC of CRP, AUC will be calculated using receiver operator characteristic (ROC) curves
Time Frame
48 hours after inclusion
Title
Compare the AUC of plasmatic NGAL and PCT.
Description
AUC for plasmatic NGAL will be compared to AUC of PCT. AUC will be calculated using receiver operator characteristic (ROC) curves
Time Frame
48 hours after inclusion
Title
Performance of urinary NGAL
Description
Define an area under receiver operator characteristic (ROC) curve based on the dosage of urinary NGAL used to diagnose renal abnormality. 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 Apparent Diffusion coefficient (ADC) mode).
Time Frame
48 hours after inclusion
Title
Performance of doppler echography
Description
The performance of doppler echography (sensitivity, specificity, positive predictive value, negative predictive value) will be established using MRI as a gold standard.
Time Frame
48 hours after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Uropathy 2nd 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tran Antoine, MD
Phone
0492030020
Ext
+33
Email
TRAN.A@pediatrie-chulenval-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ribet Chloé
Email
chloeribet@neuf.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tran Antoine, MD
Organizational Affiliation
Children Hopital of Nice CHU-Lenval Emergency
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital La Fontonne
City
Antibes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CLARA SCHORI FORTIER, MD
First Name & Middle Initial & Last Name & Degree
CHLOE RIBET
Email
chloeribet@neuf.fr
First Name & Middle Initial & Last Name & Degree
CLARA SCHORI FORTIER, MD
First Name & Middle Initial & Last Name & Degree
KHALFI, MD
First Name & Middle Initial & Last Name & Degree
MARRO, MD
Facility Name
Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tran Antoine, MD
Phone
0492030020
Email
tran.a@pediatrie-chulenval-nice.fr
First Name & Middle Initial & Last Name & Degree
Ribet Chloé
Email
cloeribet@neuf.fr

12. IPD Sharing Statement

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

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