Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-02 @ 2:35 AM
Study NCT ID:
NCT03835104
Status:
TERMINATED
Last Update Posted:
2021-06-03
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is a cluster randomized controlled trial. The general practice is the unit of cluster.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 868}}, 'statusModule': {'whyStopped': 'Covid pandemic caused recruitment to stop', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Final diagnosis', 'timeFrame': '30 days', 'description': '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.'}, {'measure': 'Duration of symptoms', 'timeFrame': '30 days', 'description': 'For all children, the duration of symptoms after the index date based on patient diaries'}, {'measure': 'Healthcare resource use', 'timeFrame': '30 days', 'description': 'For all children, re-consultation rates in ambulatory care after the index date'}, {'measure': 'Healthcare resource use', 'timeFrame': '30 days', 'description': 'For all children, ED attendance after the index date'}, {'measure': 'Healthcare resource use', 'timeFrame': '30 days', 'description': 'For all children, hospital admission after the index date'}], 'primaryOutcomes': [{'measure': 'Urinary tract infection', 'timeFrame': '3 days', 'description': 'The number of children with a urinary tract infection based on urine culture'}], 'secondaryOutcomes': [{'measure': 'Serious infections', 'timeFrame': '30 days', 'description': 'The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnosis', 'sensitivity and specificity', 'serious infections'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '34633441', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely children presenting to ambulatory care.\n\nThe 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.\n\nThe 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.\n\nThose 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.\n\nTreatment and other management decisions will be left to the treating physicians' discretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 3 months to 18 years\n* Presenting to a general practice or community paediatrics\n* Acute illness of a maximum of 10 days\n* Parent or guardian is willing and able to give informed consent for participation\n\nExclusion Criteria:\n\n* Clinically unstable warranting immediate care\n* Urinary catheter in situ\n* Immunosuppressant medication taken in the previous 30 days\n* Trauma is the main presenting problem\n* Antibiotics taken in the previous 7 days\n* Children who present to community paediatrics as a result of direct GP referral'}, 'identificationModule': {'nctId': 'NCT03835104', 'acronym': 'ERNIE4', 'briefTitle': 'ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study', 'orgStudyIdInfo': {'id': 'S61991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CRP in all', 'description': '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).\n\nThere will be only 1 test at study entry', 'interventionNames': ['Device: CRP point-of-care testing']}, {'type': 'EXPERIMENTAL', 'label': 'CRP in high risk children only', 'description': '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).\n\nThere will be only 1 test at study entry', 'interventionNames': ['Device: CRP point-of-care testing']}], 'interventions': [{'name': 'CRP point-of-care testing', 'type': 'DEVICE', 'description': 'CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)', 'armGroupLabels': ['CRP in all', 'CRP in high risk children only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Ann Van den Bruel, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ACHG, KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ann Van den Bruel', 'investigatorAffiliation': 'KU Leuven'}}}}