ChildrenNCT02496559
Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
A study testing Pre-consultation CRP in people with Children, run by NORCE Norwegian Research Centre AS.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Children
- What is being tested?
- Pre-consultation CRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 0-6 years with fever and/or respiratory symptoms
Who cannot join
- Children older than 6 years with other conditions
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Children
- Being tested
- Pre-consultation CRP
- Keywords
- C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-consultation CRPProcedure or surgery
Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Pre-consultation CRP |
| CRP requested | No intervention | No intervention, the consultation with children as normal, the CRP is used at doctors request. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic prescription rate
Number of participants prescribed antibiotics
Measured: 24 hours
Secondary outcomes (3)
Hospitalization rate
Number of participants referred to hospital
Measured: 24 hours
Rate of side-effects of antibiotics
Number of participants with side-effects of antibiotics prescribed at Out-of-hours Service
Measured: 7 days
Duration of illness
Number of days with fever and respiratory symptoms after the consultation at the Out-of-hours Service.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJul 2015
Why it stopped: Lower prevalence than expected and the inclusion was difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Steinar Hunskår, Prof. dr.med, Study director, NORCE Norwegian Research Centre AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496559
- Sponsor's protocol ID
- NKLM 2012/1471 RV
- Status last verified
- Dec 2015
- First submitted
- 25 Jun 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21266341Van 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.
PubMed 21653621Nordlie AL, Andersen BM. [Changes in antibiotic consumption among day-care children in Oslo]. Tidsskr Nor Laegeforen. 2007 Nov 15;127(22):2924-6. Norwegian.
PubMed 18026237Rebnord 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.
PubMed 22643151Magnus 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.
PubMed 22627867Alvsaker 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.
PubMed 38265029Rebnord 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.
PubMed 28096254Rebnord 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.
PubMed 27173814
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children With Fever and Respiratory Symptoms at Out-of-hours Services in Norway
- ClinicalTrials.gov ID
- NCT02496559
- Acronym / sponsor ID
- NKLM 2012/1471 RV
- Conditions
- Children
- Keywords
- C-reactive Protein, Primary Health Care, Child Welfare, After-Hours Care, Anti-Bacterial Agents, Drug Prescriptions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower prevalence than expected and the inclusion was difficult.
- Enrolment
- 401 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-consultation CRP | Active comparator | Procedure: Pre-consultation CRPEvery third child included get a CRP-test before the consultation and the doctor have the answer at start of consultation |
| CRP requested | No intervention | –No intervention, the consultation with children as normal, the CRP is used at doctors request. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 0-6 years with fever and/or respiratory symptoms
Key exclusion criteria (1 listed)
- Children older than 6 years with other conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-consultation CRPUse of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention) | Procedure or surgery | Pre-consultation CRP |
Primary outcome
Antibiotic prescription rate
Time frame: 24 hours
Number of participants prescribed antibiotics
3 secondary outcomes
Hospitalization rate
Time frame: 24 hours
Rate of side-effects of antibiotics
Time frame: 7 days
Duration of illness
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Lower prevalence than expected and the inclusion was difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 21266341Brent 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.
- Background: PubMed 21653621Van 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.
- Background: PubMed 18026237Nordlie AL, Andersen BM. [Changes in antibiotic consumption among day-care children in Oslo]. Tidsskr Nor Laegeforen. 2007 Nov 15;127(22):2924-6. Norwegian.
- Results publication: PubMed 22643151Rebnord 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.
- Results publication: PubMed 22627867Magnus 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.
- Derived from this study: PubMed 38265029Alvsaker 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.
- Derived from this study: PubMed 28096254Rebnord 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.
- Derived from this study: PubMed 27173814Rebnord 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.
- Project web pageLink provided by the sponsor.
Related trials for Children
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steinar Hunskår, Prof. dr.med study director
NORCE Norwegian Research Centre AS
Questions about this trial
What is this clinical trial studying?
A study testing Pre-consultation CRP in people with Children, run by NORCE Norwegian Research Centre AS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lower prevalence than expected and the inclusion was difficult.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic prescription rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02496559, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.