Urinary Tract InfectionsPerf-NGAL-IUNCT04191785
Evaluation of the Plasmatic NGAL as a Predictive Marker of Renal Injury in Children With Urinary Infection. (Perf-NGAL-IU)
A study testing plasmatic NGAl and MRI in people with Urinary Tract Infections, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- plasmatic NGAl and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2020to 26 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- plasmatic NGAl and MRI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasmatic NGAl and MRIDiagnostic test
Determination of plasma NGAL protein during routine blood test Realization of a reno vesical MRI at 48 hours of inclusion
| Study group | Role | What they receive |
|---|---|---|
| plasmatic NGAL and MRI | Experimental | Not described Receives: Diagnostic Test: plasmatic NGAl and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours after inclusion
Secondary outcomes (7)
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
Measured: 48 hours after inclusion
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.
Measured: 48 hours after inclusion
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
Measured: 48 hours after inclusion
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
Measured: 48 hours after inclusion
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
Measured: 48 hours after inclusion
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).
Measured: 48 hours after inclusion
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.
Measured: 48 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start11 Mar 2020
- Primary completion20 Apr 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tran Antoine, MD, Principal investigator, Children Hopital of Nice CHU-Lenval Emergency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191785
- Sponsor's protocol ID
- 18-HPNCL-08
- Acronym
- Perf-NGAL-IU
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2019
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04191785
- Acronym / sponsor ID
- Perf-NGAL-IU / 18-HPNCL-08
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| plasmatic NGAL and MRI | Experimental | Diagnostic Test: plasmatic NGAl and MRI |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasmatic NGAl and MRIDetermination of plasma NGAL protein during routine blood test Realization of a reno vesical MRI at 48 hours of inclusion | Diagnostic test | plasmatic NGAL and MRI |
Primary outcome
Compare plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) with gold standard Reno vesical Magnetic Resonance Imaging (MRI)
Time frame: 48 hours after inclusion
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).
7 secondary outcomes
Define performance of plasmatic NGAL for the diagnostic of renal abnormality due to a pyelonephritis
Time frame: 48 hours after inclusion
Performance and area under the curve (AUC) of C-reactive Protein (CRP) for the diagnostic of pyelonephritis
Time frame: 48 hours after inclusion
Performance and area under the curve (AUC) of Procalcitonin (PCT) for the diagnostic of pyelonephritis
Time frame: 48 hours after inclusion
Compare the AUC of plasmatic NGAL and CRP
Time frame: 48 hours after inclusion
Compare the AUC of plasmatic NGAL and PCT.
Time frame: 48 hours after inclusion
Performance of urinary NGAL
Time frame: 48 hours after inclusion
Performance of doppler echography
Time frame: 48 hours after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tran Antoine, MD principal investigator
Children Hopital of Nice CHU-Lenval Emergency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasmatic NGAl and MRI in people with Urinary Tract Infections, run by Fondation Lenval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) with gold standard Reno vesical Magnetic Resonance Imaging (MRI) (time frame: 48 hours after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.