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

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

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.

Study Overview

• Status: Terminated
• Conditions: Infection
• Intervention / Treatment: Device: CRP point-of-care testing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 868
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CRP in all; 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; CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
Experimental: CRP in high risk children only; 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; CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final diagnosis	For children not admitted to hospital, the final diagnosis based on all available clinical information from ambulatory care assessment over 30 days after the index date.	30 days
Duration of symptoms	For all children, the duration of symptoms after the index date based on patient diaries	30 days
Healthcare resource use	For all children, re-consultation rates in ambulatory care after the index date	30 days
Healthcare resource use	For all children, ED attendance after the index date	30 days
Healthcare resource use	For all children, hospital admission after the index date	30 days

Collaborators and Investigators

• Sponsor: KU Leuven
• Investigators: Principal Investigator: Ann Van den Bruel, MD PhD, ACHG, KU Leuven

Publications and helpful links

General Publications

• Boon HA, De Burghgraeve T, Verbakel JY, Van den Bruel A. Point-of-care tests for pediatric urinary tract infections in general practice: a diagnostic accuracy study. Fam Pract. 2022 Jul 19;39(4):616-622. doi: 10.1093/fampra/cmab118.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): May 22, 2020
• Study Completion (Actual): May 22, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: diagnosis; sensitivity and specificity; serious infections
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: S61991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No