The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a double-blind randomised placebo-controlled trial - The early use of Antibiotics in at Risk Children with InfluEnza-ARCHIE

niversity of Oxford0 sites650 target enrollmentOctober 10, 2013

Overview

No summary available.

Registry

who.int

Start Date

October 10, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Aged 6 months to 12 years inclusive.
•In ‘at risk’ category\*.
•Presenting with influenza\-like illness (i.e. cough and fever\*\*) during influenza season.
•Presenting within 5 days of symptom onset.
•Permanently registered at a general practice in England.
•Parent /guardian able to complete study diary and questionnaires.
•\*’At risk’ categories:
•The following ‘at risk’ categories are intended to guide clinicians in identifying which children are likely to be at greater risk of influenza\-related clinical deterioration or complications. However, healthcare professionals should also use their own clinical judgement to identify ‘at risk’ children and may discuss children whom they think may be ‘at risk’ with a medically qualified member of the research team.
•Respiratory
•Asthma requiring continuous or repeated use of controller therapy (e.g. inhaled steroids, leukotriene receptor antagonists, long\-acting beta agonists, systemic steroids)

•Known contraindication to co\-amoxiclav.
•Child given antibiotics within the last 72 hours.
•Child requires immediate antibiotics or hospital admission (clinician’s judgement).
•Presence of any reason to prevent healthcare professional from obtaining high nasal swab.
•Child with known cystic fibrosis.
•Child previously entered into the ARCHIE study.
•Child has been involved in another medicinal trial within the last 90 days.