The early use of Antibiotics in at Risk CHildren with InfluEnza-ARCHIE

Phase 1

• Conditions: Influenza or influenza-like illness; MedDRA version: 16.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002822-21-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-10
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

•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.

Notes:
*’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)
•Admitted to hospital with exacerbation of asthma within the last 12 months.
•Admitted to hospital with bronchiolitis within the last 12 months.
•Recurrent viral wheeze (3 or more episodes within the last 12 months).
•Bronchopulmonary dysplasia.
Cardiac
•Congenital heart disease being actively managed or monitored by cardiology team.
•Chronic heart failure being actively managed or monitored by cardiology team.
Neurological
•Chronic neurological or neuromuscular disorder which compromises respiratory function (e.g. cerebral palsy).
Renal
•Chronic kidney disease defined as either of the following:
•Impaired eGFR (estimated glomerular filtration rate) measurement within the last 12 months.
•Known hereditary or structural kidney abnormality with or without impairment in eGFR.
•Nephrotic syndrome.
•Kidney transplantation.
Liver
•Cirrhosis
•Biliary atresia
•Chronic hepatitis
Immunodeficiency
•Asplenia or splenic dysfunction.
•HIV infection.
•Undergoing chemotherapy leading to immunosuppression.
•Taking systemic steroids at a dose equivalent to prednisolone 20mg or more per day (any age) or >=1mg per kg per day (children under 20kg).
Other
•Diabetes mellitus (type 1 or type 2) or other metabolic condition.
•Genetic abnormality (e.g. Down’s syndrome)
•Sickle cell disease
•Malignancy
•Prematurity (born before 37 weeks gestation) in children aged 6 to 23 months.

Impaired eGFR is defined as an eGFR measurement of 59 ml/min/1.73m2 or less within the last 12 months before study entry. However, to enter the trial the following two conditions must also be satisfied: 1) eGFR >=30 ml/min/1.73m2 based on most recent measurement within the last 12 months; 2) no reason to suspect further deterioration in eGFR at time of study entry.

Children with mild or moderate liver disease may enter the trial. Children wi

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified