ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children

Study Overview
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Brief Summary
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This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract infections in acutely ill children presenting to ambulatory care. The accuracy of this novel test will be compared to the accuracy of conventional dipstick testing. In addition, the evidence on urine tests will be added to the existing algorithm for diagnosing serious infections in children. Finally, the study aims to describe the relation between the CRP level at study entry and the duration of symptoms and final diagnosis over the following 30 days.

Detailed Description
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The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care. The cross-sectional cohort study will compare an innovative urine test with conventional dipstick testing to establish their relative accuracy to diagnose urinary tract infections, and construct an algorithm consisting of clinical features, urine test results and CRP point-of-care testing to identify serious infections. The longitudinal follow-up study will describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at first contact. The study will run in general practices and community paediatrics in Flanders. Recruitment to the study is expected to last 18 months, with each patient entering the study only once. Children and their parents/guardians will be approached for possible participation in the study by practice staff. There is only one study visit. Those who agree to participation via written informed consent will have demographics and clinical features recorded. All children will be asked to provide a urine sample on study entry. Subsequently, CRP point-of-care testing will be conducted in all children testing positive on a clinical prediction rule, and in a random sample of children testing negative on that rule. Follow-up information for all children will be collected using general practice notes, hospital records and direct patient/parent contact. Treatment and other management decisions will be left to the treating physicians' discretion.

Official Title
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Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study

Conditions
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Infection

Intervention / Treatment
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* Device: CRP point-of-care testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 3 months to 18 years Presenting to a general practice or community paediatrics Acute illness of a maximum of 10 days Parent or guardian is willing and able to give informed consent for participation Exclusion Criteria: Clinically unstable warranting immediate care Urinary catheter in situ Immunosuppressant medication taken in the previous 30 days Trauma is the main presenting problem Antibiotics taken in the previous 7 days Children who present to community paediatrics as a result of direct GP referral

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a cluster randomized controlled trial. The general practice is the unit of cluster.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRP in all<br>All children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry | Device: CRP point-of-care testing<br>* CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)<br>|
| Experimental: CRP in high risk children only<br>Children who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott). There will be only 1 test at study entry | Device: CRP point-of-care testing<br>* CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection | The number of children with a urinary tract infection based on urine culture | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious infections | The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnosis, sensitivity and specificity, serious infections