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Contact Information:

Dr Sharon Tonner
-
sharon.tonner@phc.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - The early use of antibiotics for at risk children with influenza
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The early use of antibiotics for at risk children with influenza

Not Recruiting

Open to: All Genders

Age: Child

Oxford $location.addressLine3

Medical Conditions

Influenza and influenza-like illness

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Flu (influenza) and flu-like illness are among the most common reasons why parents and carers take children to see a doctor or nurse in winter. Flu is a viral infection that just causes a mild cough or cold in most children. However, when some children get flu, they develop bacterial infections, such as chest or ear infections, which can make them feel even more unwell. 'At risk' children with underlying medical conditions such as asthma and diabetes are particularly prone to becoming more unwell from bacterial infections if they get flu. The aim of this study is to find out whether giving an antibiotic called co-amoxiclav to 'at risk' children within 5 days of them becoming ill with flu or flu-like illness might:
1. Help stop them from developing bacterial infections and becoming more unwell
2. Help them get better more quickly
3. Affect how well antibiotics work against similar infections in future

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:

01 Oct 2014 20 Apr 2018

Publications

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29769256 protocol2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33737410/ (added 22/03/2021)2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35428613/ Economic analysis (added 19/04/2022)

A healthcare professional gains consent for each child to take part in the study from a parent or guardian. The healthcare professional then records some details about the child's flu-like illness. A nose swab and, if possible, a throat swab is taken from each child. Each child is randomly allocated to either receive an antibiotic (co-amoxiclav) or a placebo (dummy). Parents and guardians are asked to give children one dose of medication twice a day for five days and to fill in a study diary. Parents and guardians are asked if they would be willing for their child to have further optional throat swabs after 3, 6 and 12 months.


'At risk' children between 6 months and 12 years of age, who see a doctor or nurse within the first five days of developing flu or flu-like illness. 'At risk' children include children with medical conditions such as asthma, diabetes, cancer, cerebral palsy, Down's syndrome, heart problems, kidney problems and liver problems. 'At risk' children also include children under 2 years of age who were born prematurely.

You can take part if:


Current inclusion criteria as of 09/08/2017:
1. Male and female, aged 6 months to 12 years inclusive
2. In 'at risk' category, including:
2.1. Aged under 2 years and born prematurely
2.2. Respiratory/renal conditions
2.3. Cardiac conditions/cancer/cerebral palsy
2.4. Hepatic/haematological conditions
2.5. Immunodeficiency
2.6. Endocrine/metabolic conditions
3. Presenting with influenza-like illness (i.e., cough and fever) during influenza season
4. Presenting within 5 days of symptom onset
5. Permanently registered at a general practice in UK
6. Parent/guardian able to comple


You may not be able to take part if:


Current exclusion criteria as of 09/08/2017:1. Known contraindication to co-amoxiclav2. Child given antibiotics for treatment of an acute infection within the last 72 hours3. Child requires immediate antibiotics (clinician’s judgement)4. Child requires immediate hospital admission for treatment of an influenza-related complication (clinician’s judgement)5. Child has been observed on hospital ward or ambulatory care unit for longer than 24 hours6. Presence of any reason to prevent healthcare professional from obtaining nasal swab7. Child with known cystic fibrosis8. Child previously entered into the ARCHIE study9. Child has been involved in another medicinal trial within the last 90 days

Previous exclusion criteria:1. Known contraindication to co-amoxiclav2. Child given antibiotics within the last 72 hours3. Child requires immediate antibiotics or hospital admission (clinician’s judgement)4. Presence of any reason to prevent healthcare professional from obtaining high nasal swab5. Child with known cystic fibrosis6. Child previously entered into the ARCHIE study7. Child has been involved in another medicinal trial within the last 90 days


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Nuffield Department of Primary Care Health Sciences
    Oxford
    OX2 6GG
  • 80 active sites (most of them GP practices) - please see study website (www.archiestudy.com) for complete list of recruiting centres
    -

This study will help to work out whether giving antibiotics to 'at risk' children early on when they have flu or flu-like illness is worthwhile. It may also help the government plan how to use antibiotics during future flu epidemics or pandemics (which is when lots of people get flu all at once). The study medication may help children get better more quickly and/or prevent them from becoming more unwell from a bacterial infection. However, this is not known for sure until the end of the study.

Dr Sharon Tonner
-
sharon.tonner@phc.ox.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford (UK) and funded by National Institute for Health Research.



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Read full details for Trial ID: ISRCTN70714783

Or CPMS 15212

Last updated 19 April 2022

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