Title

Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care (ARTIC PC)

Principal / Lead Investigator

• Prof Paul Little, University of Southampton

Co-Investigators

• Dr Peter Blair, University of Bristol
• Prof Chris Butler, University of Oxford
• Prof Saul Faust, University of Southampton
• Dr Nick Francis, Cardiff University
• Prof Anthony Harnden, Oxford University
• Prof Alastair Hay, University of Bristol
• Prof Kerenza Hood, Cardiff University
• Prof Michael Sharland, St George's University of London
• Dr Beth Stuart, University of Southampton
• Prof Michael Moore, University of Southampton
• Dr Geraldine Leydon, University of Southampton
• Dr Kay Wang, University of Oxford
• Prof Theo Verheij, Utrecht University
• Dr Guiqing Yao, University of Southampton
• Dr Berna Broekhuizen, UMC Utrecht
• Prof Robert Read, University of Southampton

Type of study

RCT nested in an observational study

Summary

Although chest infections are one of the commonest infections managed in children seen in primary care there have been no placebo controlled studies to show what effect antibiotics have - in contrast to adults where there is now good evidence to show that for most people antibiotics do not work, and also modest effects in important subgroups of patients. The trouble with prescribing for most children is that we are using antibiotics too much which is causing the bacteria to become resistant, which is likely to lead in the future to serious infections for our children becoming untreatable from superbugs. Most children who see the doctor with a chest infection currently get antibiotics, and the groups of children that are even more likely to get antibiotic at the moment are those who have one or more particular features - phlegm (sputum), fever, shortness of breath, or rattly noises heard in the chest when the doctor listens with the stethoscope.

It is a real priority to show which groups of children that GPs prescribe for currently benefit and which do not, so that antibiotics can be targeted appropriately and the effectiveness of antibiotics can be conserved for future generations. Almost 1000 children with chest infections presenting in primary care will get either amoxicillin (an antibiotic) or not get amoxicillin for 1 week to see whether antibiotics make any difference to symptom severity, or the duration of illness.

All children will be given advice about using pain killers and will be followed up carefully during the next month. The study will be large enough to be able to show which, if any, groups of children that GPs currently prescribe for benefit from antibiotics (such as those with fever compared to those with no fever), and which groups do not. Parents and children who are happy to have further tests will have a pinprick blood sample, a swab of the throat and an X ray done. This is to see whether simple markers of inflammation and infection or the presence of bacteria, or any lung involvement seen on the X ray can predict benefit from antibiotics.

Who is the study sponsor?

University of Southampton

UKCRN portfolio number

NIHR HTA - 13/34/64

Funder

NIHR HTA 

Total grant value

£1,595,352.00

Amount accruing to your group 

tbc

Start date

01/11/2015

End date

30/11/2018

Potential benefit to patients

On the assumption that the trial might demonstrate moderate benefit of antibiotic both overall and among subgroups, the potential benefits of the trial might include: 

1. Reduced medicalisation and fewer unnecessary GP consultations in future episodes of LRTI
2. Reduced risk of anti-microbial resistance
3. Improved quality of care by providing evidence-based information to patients (parents) and reduced unwanted side effects in children

Further information 

Study profile on NIHR website: http://www.nets.nihr.ac.uk/projects/hta/133464

Outputs generated (Reports / Publications / Impact)

Details to follow