The early use of antibiotics for at risk children with influenza

Not Applicable

Completed

• Conditions: Influenza and influenza-like illness; Respiratory; Influenza, virus not identified

• Registration Number: ISRCTN70714783
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-11
• Study Completion: 2019-05-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children re-consulting due to clinical deterioration within 28 days of study entry