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

Infection Clinical Trial

— ERNIE4  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03835104
• Other study ID #: S61991
• Status: Terminated
• Phase: N/A
• Start date: February 12, 2019
• Est. completion date: May 22, 2020

Study information

• Verified date: May 2021
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 868
• Est. completion date: May 22, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

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)

Locations

Country	Name	City	State
Belgium	KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Duration of symptoms	For all children, the duration of symptoms after the index date based on patient diaries	30 days
Other	Healthcare resource use	For all children, re-consultation rates in ambulatory care after the index date	30 days
Other	Healthcare resource use	For all children, ED attendance after the index date	30 days
Other	Healthcare resource use	For all children, hospital admission after the index date	30 days
Primary	Urinary tract infection	The number of children with a urinary tract infection based on urine culture	3 days
Secondary	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