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

NCT03835104 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 868

Last updated 2021-06-03

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • KU Leuven

    lead OTHER

Principal Investigators

  • Ann Van den Bruel, MD PhD · ACHG, KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2020-05-22
Completion
2020-05-22

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835104 on ClinicalTrials.gov