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:
NORCE Norwegian Research Centre AS
Organization:
Study Overview
Official Title:
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lower prevalence than expected and the inclusion was difficult.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: