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

NCT ID: NCT03835104

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 868 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2020-05-22

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.

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.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

CRP point-of-care testing

Intervention Type: 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 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

Group Type: EXPERIMENTAL

CRP point-of-care testing

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Ann Van den Bruel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Van den Bruel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

ACHG, KU Leuven

Locations

KU Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34633441 (View on PubMed)

Other Identifiers

S61991

Identifier Type: -

Identifier Source: org_study_id