Clinical trial NCT03835104: ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children
Official title: Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infection
Keywords: diagnosis
sensitivity and specificity
serious infections
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 868
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a cluster randomized controlled trial. The general practice is the unit of cluster.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Urinary tract infection
timeFrame: 3 days
Secondary outcomes:
measure: Serious infections
timeFrame: 30 days
Other outcomes:
measure: Final diagnosis
timeFrame: 30 days
measure: Duration of symptoms
timeFrame: 30 days
measure: Healthcare resource use
timeFrame: 30 days
measure: Healthcare resource use
timeFrame: 30 days
measure: Healthcare resource use
timeFrame: 30 days
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
affiliation: ACHG, KU Leuven
name: Ann Van den Bruel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.