Evaluation of the Plasmatic NGAL as a Predictive Marker of Renal Injury in Children With Urinary … (NCT04191785) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Plasmatic NGAL as a Predictive Marker of Renal Injury in Children With Urinary Infection. (Perf-NGAL-IU)
France50 participantsStarted 2020-03-11
Plain-language 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
Who can participate
Age range
4 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study compared a blood test called NGAL to MRI scans to detect kidney damage from urinary tract infections in children, can you tell me whether NGAL testing is something you already use or plan to use in my child's care, based on findings like this?
2This trial is now completed — have the results been published yet, and if so, what did they show about how well the NGAL blood test predicted kidney injury compared to the MRI?
3If my child has a urinary tract infection, how do you currently decide whether to check for kidney damage, and could a simpler blood test like NGAL change that approach for us?
4MRI is described as the gold standard for checking kidney involvement in this study — is that a test you would recommend for my child, and what would the results mean for their treatment plan?
5Are there any next steps or follow-up studies coming out of this research that my child might be eligible for, or that could influence the care options available to us?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare plasmatic Neutrophil Gelatinase-Associated Lipocalin (NGAL) with gold standard Reno vesical Magnetic Resonance Imaging (MRI)