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

NCT03835104 | Terminated

• 1 other identifier: S61991
• Study Type: interventional
• Target: 868
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection

Keywords

diagnosis; sensitivity and specificity; serious infections

Outcome Measures

Primary Outcomes (1)

• Urinary tract infection

  The number of children with a urinary tract infection based on urine culture

  3 days

Secondary Outcomes (1)

• Serious infections

  30 days

Other Outcomes (5)

• Final diagnosis

  30 days

• Duration of symptoms

  30 days

• Healthcare resource use

  30 days

Study Arms (2)

CRP in all

ACTIVE COMPARATOR

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 in high risk children only

EXPERIMENTAL

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

Interventions

CRP point-of-care testing DEVICE

CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)

CRP in all; CRP in high risk children only

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34633441 DERIVED

MeSH Terms

Conditions

Infections; Disease; Hypersensitivity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Ann Van den Bruel, MD PhD

  ACHG, KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study is a cluster randomized controlled trial. The general practice is the unit of cluster.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 8, 2019
• Study Start: February 12, 2019
• Primary Completion: May 22, 2020
• Study Completion: May 22, 2020
• Last Updated: June 3, 2021

Record last verified: 2021-05

Locations

BE (1)