Influenza or influenza-like illness MedDRA version: 16.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Co-amoxiclav 400 mg/57 mg/5 ml Sugar Free Powder for Oral Suspension
Product Name: Co-amoxiclav 400 mg/57 mg/5 ml Sugar Free Powder for Oral Suspension
Phar
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether early treatment with co-amoxiclav reduces the likelihood of re-consultation due to clinical deterioration in ‘at risk’ children with influenza/influenza-like illness (ILI) within 28 days of study entry.; Secondary Objective: 1. To determine whether early treatment with co-amoxiclav reduces duration of fever in ‘at risk’ children with influenza/ILI. 2. To determine whether early treatment with co-amoxiclav reduces duration of symptoms in ‘at risk’ children with influenza/ILI. 3. To compare further intervention rates in ‘at risk’ children with influenza/ILI treated with co-amoxiclav versus placebo. 4. To compare adverse events in ‘at risk’ children with influenza/ILI treated with co-amoxiclav versus placebo. Other objectives: 5. To develop and validate risk scores for influenza-related clinical deterioration and complications for use in children with influenza/ILI. 6. To explore the cost-effectiveness of different potential strategies for early antibiotic use in ‘at risk’ children with influenza/ILI. 7. To examine the impact on antibiotic resistance of early co-amoxiclav use in ‘at risk’ children with influenza/ILI. 8. To determine the impact on long-term respiratory bacterial carriage of early co- ; Primary end point(s): The proportion of children re-consulting due to clinical deterioration within 28 days of study entry. The first re-consultation episode will be used. Re-consultation is defined as any subsequent visit to a general practice, emergency walk-in centre, out-of-hours primary care centre or Accident and Emergency (A+E) department within 28 days of entering the trial. Clinical deterioration is defined as any of: worsening symptoms, development of new symptoms or development of a complication requiring medication or hospitalisation af | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration of fever from time of study entry. • Duration of symptoms from time of study entry. • Proportion of children prescribed medication (e.g. antibiotics, steroids) and/or requiring further investigations (e.g. chest X-ray) within 28 days of study entry. • Proportion of children in whom adverse events are reported within 28 days of study entry. • Proportion of children who are hospitalised or die within 28 days of study entry. • Health-related quality of life using the EQ-5D-Y and EQ-5D-Y proxy on days 1, 4, 7, 14 and 28. • Healthcare resource utilisation and parental/informal care costs within 28 days of study entry. • Minimum inhibitory concentrations (MICs) of alpha-haemolytic streptococci (including Streptococcus pneumoniae), Haemophilus influenzae and Staphylococcus aureus in relation to a representative range of antibiotics 3 months, 6 months and 12 months after study entry. • Proportion of ampicillin-resistant alpha-haemolytic streptococci (including Streptococcus pneumoniae), Haemophilus influenzae and Staphylococcus aureus 12 months after study entry. • Prevalence of alpha-haemolytic streptococci (including Streptococcus pneumoniae), Haemophilus influenzae and Staphylococcus aureus at 12 months after study entry. ;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months post randomisation. | — |
Countries
United Kingdom
Contacts
Public ContactArchie Trial Manager
University of Oxford
Outcome results
None listed