Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-28 @ 1:19 AM
Study NCT ID:
NCT02496559
Status:
TERMINATED
Last Update Posted:
2015-12-03
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'whyStopped': 'Lower prevalence than expected and the inclusion was difficult.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-07-09', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antibiotic prescription rate', 'timeFrame': '24 hours', 'description': 'Number of participants prescribed antibiotics'}], 'secondaryOutcomes': [{'measure': 'Hospitalization rate', 'timeFrame': '24 hours', 'description': 'Number of participants referred to hospital'}, {'measure': 'Rate of side-effects of antibiotics', 'timeFrame': '7 days', 'description': 'Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service'}, {'measure': 'Duration of illness', 'timeFrame': '7 days', 'description': 'Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['C-reactive Protein', 'Primary Health Care', 'Child Welfare', 'After-Hours Care', 'Anti-Bacterial Agents', 'Drug Prescriptions'], 'conditions': ['Children']}, 'referencesModule': {'references': [{'pmid': '21266341', 'type': 'BACKGROUND', 'citation': 'Brent AJ, Lakhanpaul M, Thompson M, Collier J, Ray S, Ninis N, Levin M, MacFaul R. Risk score to stratify children with suspected serious bacterial infection: observational cohort study. Arch Dis Child. 2011 Apr;96(4):361-7. doi: 10.1136/adc.2010.183111. Epub 2011 Jan 24.'}, {'pmid': '21653621', 'type': 'BACKGROUND', 'citation': 'Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.'}, {'pmid': '18026237', 'type': 'BACKGROUND', 'citation': 'Nordlie AL, Andersen BM. [Changes in antibiotic consumption among day-care children in Oslo]. Tidsskr Nor Laegeforen. 2007 Nov 15;127(22):2924-6. Norwegian.'}, {'pmid': '22643151', 'type': 'RESULT', 'citation': 'Rebnord IK, Sandvik H, Hunskaar S. Use of laboratory tests in out-of-hours services in Norway. Scand J Prim Health Care. 2012 Jun;30(2):76-80. doi: 10.3109/02813432.2012.684208.'}, {'pmid': '22627867', 'type': 'RESULT', 'citation': 'Magnus MC, Vestrheim DF, Nystad W, Haberg SE, Stigum H, London SJ, Bergsaker MA, Caugant DA, Aaberge IS, Nafstad P. Decline in early childhood respiratory tract infections in the Norwegian mother and child cohort study after introduction of pneumococcal conjugate vaccination. Pediatr Infect Dis J. 2012 Sep;31(9):951-5. doi: 10.1097/INF.0b013e31825d2f76.'}, {'pmid': '38265029', 'type': 'DERIVED', 'citation': 'Alvsaker LKT, Stensen MF, Mjelle AB, Hunskaar S, Rebnord IK. Outcomes of antibiotic treatment for respiratory infections in children an observational study in primary care. Scand J Prim Health Care. 2024 Jun;42(2):237-245. doi: 10.1080/02813432.2024.2305929. Epub 2024 Jan 24.'}, {'pmid': '28096254', 'type': 'DERIVED', 'citation': 'Rebnord IK, Sandvik H, Mjelle AB, Hunskaar S. Factors predicting antibiotic prescription and referral to hospital for children with respiratory symptoms: secondary analysis of a randomised controlled study at out-of-hours services in primary care. BMJ Open. 2017 Jan 17;7(1):e012992. doi: 10.1136/bmjopen-2016-012992.'}, {'pmid': '27173814', 'type': 'DERIVED', 'citation': 'Rebnord IK, Sandvik H, Mjelle AB, Hunskaar S. Out-of-hours antibiotic prescription after screening with C reactive protein: a randomised controlled study. BMJ Open. 2016 May 12;6(5):e011231. doi: 10.1136/bmjopen-2016-011231.'}], 'seeAlsoLinks': [{'url': 'http://uni.no/en/uni-health/national-centre-for-emergency-primary-health-care/diagnostic-equipment-at-norwegian-out-of-hours-services/', 'label': 'Project web page'}]}, 'descriptionModule': {'briefSummary': 'Viral self-limiting infections in respiratory organs among children are common in primary care. Serious infections have low prevalence and are challenging to distinguish from self-limiting infections.\n\nPrescription of antibiotics in primary care is still high but stable since 2009 in Norway, and 90% of all antibiotics are prescribed in primary care.\n\nC-reactive protein (CRP) has been especially popular in Norway for point-of-care testing in primary care, but its role in ruling-out serious infections and the cut-off value for prescribing antibiotics has been discussed a lot.\n\nThe aim of this study is to identify if pretesting with CRP of all children 0-6 year with fever or respiratory symptoms at Out-of-Hours Services will affect the prescription of antibiotics and the referral to hospital for children.', 'detailedDescription': "Design: A randomized controlled observational study including children 0-6 year with fever and/or respiratory symptoms at 4 different Out-of-hour Services and at 1 Emergency Children Department Clinic at a hospital (open clinic). The data consist of clinical data and anamnestic information from a nurse at OOH-service collected before the consultation, the doctor's journal and a questionnaire to parents before the consultation and 1 week after the consultation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 0-6 years with fever and/or respiratory symptoms\n\nExclusion Criteria:\n\n* Children older than 6 years with other conditions'}, 'identificationModule': {'nctId': 'NCT02496559', 'briefTitle': 'Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway', 'organization': {'class': 'OTHER', 'fullName': 'NORCE Norwegian Research Centre AS'}, 'officialTitle': 'Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway', 'orgStudyIdInfo': {'id': 'NKLM 2012/1471 RV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pre-consultation CRP', 'description': 'Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation', 'interventionNames': ['Procedure: Pre-consultation CRP']}, {'type': 'NO_INTERVENTION', 'label': 'CRP requested', 'description': 'No intervention, the consultation with children as normal, the CRP is used at doctors request.'}], 'interventions': [{'name': 'Pre-consultation CRP', 'type': 'PROCEDURE', 'description': 'Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)', 'armGroupLabels': ['Pre-consultation CRP']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Steinar Hunskår, Prof. dr.med', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NORCE Norwegian Research Centre AS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}