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

niversity of Oxford (UK)0 个研究点目标入组 271 人开始时间: 2013年12月11日最近更新: 2022年5月2日

适应症

试验速览

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29769256 protocol 2021 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)

•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 complete study diary and questionnaires
•Previous inclusion criteria:
•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 England
•6. Parent/guardian able to complete study diary and questionnaires

•Current exclusion criteria as of 09/08/2017:
•1. Known contraindication to co-amoxiclav
•2. Child given antibiotics for treatment of an acute infection within the last 72 hours
•3. 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 hours
•6. Presence of any reason to prevent healthcare professional from obtaining nasal swab
•7. Child with known cystic fibrosis
•8. Child previously entered into the ARCHIE study
•9. Child has been involved in another medicinal trial within the last 90 days
•Previous exclusion criteria:
•1. Known contraindication to co-amoxiclav
•2. Child given antibiotics within the last 72 hours
•3. Child requires immediate antibiotics or hospital admission (clinician?s judgement)
•4. Presence of any reason to prevent healthcare professional from obtaining high nasal swab
•5. Child with known cystic fibrosis
•6. Child previously entered into the ARCHIE study
•7. Child has been involved in another medicinal trial within the last 90 days

发起方

niversity of Oxford (UK)