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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2015-002455-97
    Sponsor's Protocol Code Number:13381
    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:2020-07-24
    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 number2015-002455-97
    A.3Full title of the trial
    Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotics for chest infections in children consulting with the GP
    A.3.2Name or abbreviated title of the trial where available
    ARTIC PC
    A.4.1Sponsor's protocol code number13381
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN79914298
    A.5.4Other Identifiers
    Name:Sponsor R&D referenceNumber: 13381
    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 Southampton
    B.1.3.4CountryUnited Kingdom
    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 HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Southampton
    B.5.2Functional name of contact pointPaul Little
    B.5.3 Address:
    B.5.3.1Street AddressAldermoor Health Centre
    B.5.3.2Town/ cityAldermoor Close
    B.5.3.3Post codeSO16 5ST
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02380241050
    B.5.5Fax number02380701125
    B.5.6E-mailp.little@soton.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 Amoxicillin
    D.2.1.1.2Name of the Marketing Authorisation holderAthlone Laboratories Ltd (Kent Pharmaceuticals 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 nameAmoxicillin
    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
    D.3.9.1CAS number 26787-78-0
    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 number50
    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
    Respiratory tract infections in children aged between 6 months and 12 years
    E.1.1.1Medical condition in easily understood language
    Chest infections in children aged 6 months to 12 years
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066740
    E.1.2Term Acute respiratory tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10024968
    E.1.2Term Lower respiratory tract infection
    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
    Our aim is to provide evidence to inform the use of antibiotics for the management of chest infections in children. The objectives are:

    1) To estimate the effectiveness of amoxicillin overall and in key clinical subgroups of children presenting with uncomplicated (non-pneumonic) lower respiratory tract infection in primary care

    2) To estimate the cost-effectiveness of antibiotics overall and in key clinical subgroups of children presenting with uncomplicated lower respiratory tract infection in primary care

    3) To explore the estimates of effectiveness according to key pathophysiological subgroups ( the presence of bacterial pathogens; raised C reactive protein measurement or white cell count; the presence of clinically undetected consolidation on X ray; oximetry; lung function)
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    OBSERVATIONAL STUDY FOR THOSE REFUSING RANDOMISATION
    Some parents will decline randomisation, either due to concern about getting antibiotics or not getting antibiotics. The main concern for the trial data is that due to selection bias the trial may end up addressing the milder end of the clinical spectrum. Hence we propose, as in our previous adult trial, that those not consenting to randomisation are offered participation in an observational study where the same outcomes are collected so that the characteristics and outcomes can be compared with trial participants. We have allowed for up to 30% additional parents being willing to undertake the observational trial.

    NESTED QUALITATIVE STUDY
    AIMS
    (1) Prior to the start of the study itself, a small student study was undertaken to explore a range of parent (and child/patient) views to aid the design of study procedures, to help optimize the acceptability of procedures once the trial is operational (REC ref: 14/WA/1226.
    A second part of this is
    (2) To explore a range of parent (and child/patient) views on study participation, seeking to understand positive and negative experiences from start to finish.

    TIMING
    (1) Has already taken place in the months prior to the study commencement/randomization.
    (2) Will take place once participants have been randomized and participated.

    METHODS
    Semi-structured in-depth interviews will be used, but will be flexible to permit parents to speak freely on topics they deem to be relevant to ensure key emerging issues are captured. A subtle realist approach will be employed throughout the project to help represent participants’ views.

    SAMPLE
    A purposive sampling approach will be designed to elicit views of a range of parents (and children where appropriate) (including a mix of men and women/boys and girls).
    1. A total of 16 interviews took place which was deemed to be sufficient to gather detailed feedback on parent (children/patients) views to help design the trial procedures.
    2. Between 15 and 30 interviews should be adequate to represent the views of a range of parents(children/patients) following participation. Additional interviews will be conducted if saturation has not been reached.

    ANALYSIS
    We will follow the stages of Braun and Clarke’s thematic analysis, assisted by NVivo computerized analysis software. Analysis will aim to identify themes to help fulfil aims 1 and 2 whilst remaining flexible and open to emerging findings.

    QUALITY
    Standard methodological strategies will be employed to help safeguard rigour and ensure we produce trustworthy, plausible, and relevant findings. These will include careful purposive sampling, a clear exposition of methods (including field notes, and audio recording of interviews and accurate transcription of interviews, regular discussion between the fieldworker and senior qualitative researcher (including double coding/discussion of codes). Negative case analysis will help to refine analysis/safeguard against premature completion and the researcher will be tutored in the importance of a ‘reflexive’ sensitivity to the relationship between the researcher and research process.
    E.3Principal inclusion criteria
    Children between 6 months and twelve years old presenting with an acute lower respiratory infection (LRTI), defined as an acute cough as the predominant symptom, judged by the GP to be infective in origin (any of: a systemic symptom (diarrhoea, fever, raised temperature), coryza, sputum production, wheezing, sore throat, earache), lasting <21 days, and with other symptoms or signs localising to the lower tract (shortness of breath, sputum - or more likely in this age group audible secretions suggesting sputum), Parent/guardian willing and able to be contacted for follow up and complete symptom diary for up to 28 days.
    E.4Principal exclusion criteria
    The cough is judged by the clinician to have a non-infectious aetiology (e.g. hayfever or asthma) or almost certain viral aetiology (croup, where antibiotics are not commonly prescribed); immune-compromised; and antibiotic use in previous 30 days. For the trial, suspected pneumonia based on clinical examination or being very severely ill as judged by the GP is an exclusion but such children can still enter the observational study. In addition only one child from each household will be recruited. Additionally children will be eligible for trial but eligible for cohort study if the child is immune-compromised, has a history of antibiotic use in previous 30 days, has a clinical diagnosis of pneumonia, has had previous pneumonia, has focal rales, has a low oxygen saturation (<92%), has severe tachypnoea (clinician judged), has Severe Asthma requiring long-term maintenance oral steroids (as defined in the British Thoracic Society Step 5).



    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be mean duration of symptoms rated moderately bad or worse recorded for up to 28 days until symptoms settle in a validated daily diary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    Severity of symptoms
    Side effects
    Quality of Life using the EQ5-D
    Worsening symptoms or complications
    Health Care resource use
    E.5.2.1Timepoint(s) of evaluation of this end point
    Severity of symptoms in the first 2-4 days after seeing the doctor
    Side effects during the 28 days
    Quality of Life using the EQ5-D - on days 1,3,7,14,28
    Worsening symptoms or complications during the 28 days
    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 No
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 938
    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: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 938
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state938
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 938
    F.4.2.2In the whole clinical trial 938
    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
    G.4.1Name of Organisation NIHR Clinical Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-17
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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