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

Not Applicable

Terminated

• Conditions: Children

• Registration Number: NCT02496559
• Lead Sponsor: NORCE Norwegian Research Centre AS

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-06
• Study First Submitted: 2015-06-25
• Study Completion: 2015-07
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

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

Exclusion Criteria

• Children older than 6 years with other conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Antibiotic prescription rate	24 hours	Number of participants prescribed antibiotics

Secondary Outcome Measures

Name	Time	Method
Rate of side-effects of antibiotics	7 days	Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service
Duration of illness	7 days	Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
Hospitalization rate	24 hours	Number of participants referred to hospital