Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway

NCT02496559 | Terminated

• 1 other identifier: NKLM 2012/1471 RV
• Study Type: interventional
• Target: 401
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. Prescription of antibiotics in primary care is still high but stable since 2009 in Norway, and 90% of all antibiotics are prescribed in primary care. C-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. The 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.

Conditions

Children

Keywords

C-reactive Protein; Primary Health Care; Child Welfare; After-Hours Care; Anti-Bacterial Agents; Drug Prescriptions

Outcome Measures

Primary Outcomes (1)

• Antibiotic prescription rate

  Number of participants prescribed antibiotics

  24 hours

Secondary Outcomes (3)

• Hospitalization rate

  24 hours

• Rate of side-effects of antibiotics

  7 days

• Duration of illness

  7 days

Study Arms (2)

Pre-consultation CRP

ACTIVE COMPARATOR

Every third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation

Procedure: Pre-consultation CRP

CRP requested

NO INTERVENTION

No intervention, the consultation with children as normal, the CRP is used at doctors request.

Interventions

Pre-consultation CRP PROCEDURE

Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)

Pre-consultation CRP

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 0-6 years with fever and/or respiratory symptoms

You may not qualify if:

• Children older than 6 years with other conditions

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead
• Haukeland University Hospital: collaborator

Related Publications (8)

• 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: 21266341 BACKGROUND

• 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: 21653621 BACKGROUND

• 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: 18026237 BACKGROUND

• 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: 22643151 RESULT

• 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: 22627867 RESULT

• 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: 38265029 DERIVED

• 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: 28096254 DERIVED

• 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.

  PMID: 27173814 DERIVED

Related Links

• Project web page

Study Officials

• Steinar Hunskår, Prof. dr.med

  NORCE Norwegian Research Centre AS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 14, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12