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Trial record 16 of 636 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT03835104
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ann Van den Bruel, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Infection Device: CRP point-of-care testing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is a cluster randomized controlled trial. The general practice is the unit of cluster.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study
Actual Study Start Date : February 12, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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

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)

Experimental: 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

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)




Primary Outcome Measures :
  1. Urinary tract infection [ Time Frame: 3 days ]
    The number of children with a urinary tract infection based on urine culture


Secondary Outcome Measures :
  1. Serious infections [ Time Frame: 30 days ]
    The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis


Other Outcome Measures:
  1. Final diagnosis [ Time Frame: 30 days ]
    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.

  2. Duration of symptoms [ Time Frame: 30 days ]
    For all children, the duration of symptoms after the index date based on patient diaries

  3. Healthcare resource use [ Time Frame: 30 days ]
    For all children, re-consultation rates in ambulatory care after the index date

  4. Healthcare resource use [ Time Frame: 30 days ]
    For all children, ED attendance after the index date

  5. Healthcare resource use [ Time Frame: 30 days ]
    For all children, hospital admission after the index date



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835104


Contacts
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Contact: Stephanie Philippaerts, MSc +32 16 37 70 93 stephanie.philippaerts@kuleuven.be
Contact: Hanne Boon, MD +32 16 19 31 68 hanne.boon@kuleuven.be

Locations
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Belgium
KU Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ann Van den Bruel, MD PhD    +32476882968    ann.vandenbruel@kuleuven.be   
Sponsors and Collaborators
KU Leuven
Investigators
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Principal Investigator: Ann Van den Bruel, MD PhD ACHG, KU Leuven

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Responsible Party: Ann Van den Bruel, Associate Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT03835104     History of Changes
Other Study ID Numbers: S61991
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ann Van den Bruel, KU Leuven:
diagnosis
sensitivity and specificity
serious infections