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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Topic: Primary Care Research Network for England Subtopic: Not Assigned Disease: All Diseases
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Acute illness in children is one of the most common problems in general practice. In the UK, acute infections result in four consultations per person each year in children aged less than 1 year, and an average of 1.3 consultations per person each year in children aged 1-15 year. Febrile illness (seizures due to high body temperature) accounts for 20% of all visits to the paediatric emergency department.
Clinical features have moderate ability to identify a subgroup of children with an increased risk of serious infections The National Institute for Health and Care Excellence (NICE) recommends the measurement of vital signs including temperature, breathing rate and pulse in each child But studies show that primary care doctors measure temperature in less than half of children, with even lower rates for breathing rate and pulse. The use of age-adjusted percentiles may increase interpretability and therefore uptake of measuring vital signs In addition, combining the results for all vital signs has recently been shown to be able to rule out serious infections. However, the evidence also clearly shows that vital signs and other clinical features result in a fairly large number of false positives, i.e. too many children will be considered potentially at risk for a serious infection Therefore, to avoid inappropriate referral to secondary care but improve recognition at the same time, additional testing is necessary. The blood level of C-reactive protein (CRP) has moderate to good ability to rule in or rule out serious infections in children attending emergency departments or out-of-hours services (CRP is produced by the liver. If there is more CRP than usual, there is inflammation in your body). At present, point-of-care CRP tests are available that could be used in general practice. The Afinion Analyzer produces a result within minutes and requires only a finger prick with limited handling of the sample afterwards. Introducing point-of-care CRP testing in the routine management of acutely ill children may also affect doctors prescribing of antibiotics. A large trial could assess whether CRP point-of-care testing is able to assist in the early recognition of serious infections and in the improved targeting of antibiotic prescribing in children with an acute illness. However, several factors necessary for the adequate planning of such a study are unknown at present, making an initial small study necessary. The main objective is to assess how many children and parents/guardians would agree to be recruited to a trial involving a minimally invasive blood test. The other objectives are to estimate effect size - to confirm that the effect achieved by measuring blood CRP is consistent with a clinically important change in antibiotic prescription rates, referral rates, hospital admission rates, and additional testing rates In addition, we want to evaluate whether the blood test is acceptable to children and parents/guardians, feasible for a nurse, and increases diagnostic certainty for GPs.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26757989 results
You can take part if:
You may not be able to take part if:
1. Acute trauma2. Clinically unstable warranting immediate care3. Prior inclusion in the study4. Prior inclusion in another clinical trial of an investigational medicinal product in the last 90 days or any other research in the last 30 days
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
David
Timmins
david.timmins@phc.ox.ac.uk
The study is sponsored by University of Oxford (UK) and funded by National Institute for Health Research; University of Oxford.
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Or CPMS 14824
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