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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-002822-21
    Sponsor's Protocol Code Number:ARCHIE001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-002822-21
    A.3Full title of the trial
    The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care
    (ARCHIE): a double-blind randomised placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The early use of Antibiotics in at Risk CHildren with InfluEnza-ARCHIE
    A.3.2Name or abbreviated title of the trial where available
    The early use of Antibiotics in at Risk Children with InfluEnza-ARCHIE
    A.4.1Sponsor's protocol code numberARCHIE001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Oxford
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Programme Grants for Applied Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointArchie Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Primary Care Health Sciences
    B.5.3.2Town/ city23-38 Hythe Bridge Street
    B.5.3.3Post codeOX1 2ET
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865617842
    B.5.5Fax number01865289412
    B.5.6E-mailarchie@phc.ox.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Co-amoxiclav 400 mg/57 mg/5 ml Sugar Free Powder for Oral Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderBrown & Burk UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCo-amoxiclav 400 mg/57 mg/5 ml Sugar Free Powder for Oral Suspension
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmoxicillin Trihydrate
    D.3.9.1CAS number 61336-70-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium Clavulanate
    D.3.9.1CAS number 61177-45-5
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral suspension
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza or influenza-like illness
    E.1.1.1Medical condition in easily understood language
    flu or flu-like illness
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10022000
    E.1.2Term Influenza
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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-
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Nested longitudinal cohort study to explore the potential impact of early antibiotic use on antibiotic resistance and bacterial carriage for children participating in the ARCHIE trial. Researchers will obtain interval throat swab samples over the course of a year and test them for antibiotic resistance and bacterial carriage.
    E.3Principal 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 with severe liver disease may not enter the trial. Severe liver disease is defined as hepatic impairment associated with any of the following: jaundice, impaired coagulation/increased bleeding risk, bilirubin persistently greater than 50 micromol/litre (two measurements within last 12 months).

    **Fever will be defined as any of the following: child-reported fever, parent-reported fever or temperature >37.8°C (axillary or tympanic temperature measurement).
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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 after randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months post randomisation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned64
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be the date of the last medical notes review of the last trial participant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 650
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 200
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 400
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children aged 6 months to 12 years, inclusive
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state650
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 650
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-15
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