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    Summary
    EudraCT Number:2022-002955-20
    Sponsor's Protocol Code Number:ADENO-beta
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-16
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-002955-20
    A.3Full title of the trial
    Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic Adenovirus infection (ADENO-beta).
    Studio randomizzato controllato in doppio cieco versus placebo per valutare l’efficacia della mono-somministrazione di betametasone nei bambini con infezione sintomatica da Adenovirus (ADENO-beta).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy of the drug containing betamethasone given once in children with symptoms related to Adenovirus infection
    Sperimentazione clinica volta a valutare l'efficacia del medicinale contenente betametasone somministrato una volta sola in bambini che presentano simtomi legati alla infezione da Adenovirus
    A.3.2Name or abbreviated title of the trial where available
    ADENO-beta
    ADENO-beta
    A.4.1Sponsor's protocol code numberADENO-beta
    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 SponsorAOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU Città della salute e della Scienza di Torino
    B.5.2Functional name of contact pointS.C. Pediatria d'Urgenza
    B.5.3 Address:
    B.5.3.1Street AddressPiazza Polonia 94
    B.5.3.2Town/ cityTorino
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.6E-mailvgiannone@cittadellasalute.to.it
    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.2.5The 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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNBETAMETASONE
    D.3.9.1CAS number 378-44-9
    D.3.9.2Current sponsor codeBETAMETASONE
    D.3.9.3Other descriptive nameBetamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number2.5
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule, hard
    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
    Pediatric patients diagnosed with symptomatic Adenovirus infection.
    Pazienti pediatrici con diagnosi di infezione sintomatica da Adenovirus confermata.
    E.1.1.1Medical condition in easily understood language
    Pediatric patients with Adenovirus viral infection with symptoms.
    Pazienti pediatrici con infezione virale da Adenovirus con sintomi.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10060931
    E.1.2Term Adenovirus 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
    To evaluate the efficacy of single-administration betamethasone in children with adenoviral febrile infection in increasing the proportion of febrile children within 24 hours of administration
    Valutare l’efficacia della mono-somministrazione di betametasone in bambini con infezione febbrile adenovirale nell’aumentare la proporzione di bambini sfebbrati entro 24 ore dalla somministrazione
    E.2.2Secondary objectives of the trial
    The reduction of pharyngo-tonsillar pain, of the incidence and duration of hospitalizations, of the time needed to faint and the overall duration of fever.
    Riduzione del dolore faringo-tonsillare, dell’incidenza e durata dei ricoveri, del tempo necessario allo sfebbramento e della durata globale della febbre.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 6 months and 6 years (body weight between 5 and 27 kg).
    • Body temperature measured with an axillary or ear thermometer greater than 37.5 °C.
    • Clinical status compatible with Adenovirus pharyngo-tonsillar infection.
    • Adenovirus antigenic swab positivity performed with “Biosensor” rapid swab.
    • Negativity of the swab for SBEGA, if deemed necessary to perform it following Mc Isaac's criteria.
    • Informed consent form for participation in the trial signed by the caregiver.
    • Età compresa tra 6 mesi e 6 anni (peso corporeo compreso tra i 5 e i 27 kg).
    • Temperatura Corporea (TC) misurata con termometro ascellare o auricolare maggiore di 37,5°C.
    • Quadro clinico compatibile con infezione faringo-tonsillare da Adenovirus.
    • Positività al tampone antigenico per Adenovirus eseguito con tampone rapido “Biosensor”.
    • Negatività del tampone per SBEGA, se ritenuto necessario eseguirlo seguendo i criteri di Mc Isaac.
    • Modulo di consenso informato per la partecipazione alla sperimentazione sottoscritto dal caregiver.
    E.4Principal exclusion criteria
    • Patients who have taken betamethasone within 48 hours of adequate dosage.
    • Chronic underlying disease associated with an increased risk of unusual or severe adenoviral infection.
    • Inability to tolerate oral medications.
    • Documented allergy or any other known contraindication to the investigational drug.
    • Subacute or chronic conditions requiring higher betamethasone equivalent or known primary or secondary adrenal insufficiency.
    • Transfer for any reason to another hospital.
    • Parents who are unable to understand the proposed study or who cannot reliably participate in telephone follow-up due to significant language barriers.
    • Participation in another investigational drug study within 30 days prior to and during this study.
    • Pazienti che hanno assunto betametasone nelle 48 ore precedenti a dosaggio adeguato.
    • Malattia cronica sottostante associata ad un aumentato rischio di infezione adenovirale insolita o grave.
    • Incapacità di tollerare i farmaci per via orale.
    • Allergia documentata o qualsiasi altra controindicazione nota al farmaco sperimentale.
    • Condizioni subacute o croniche che richiedono un equivalente di betametasone superiore o nota insufficienza surrenalica primaria o secondaria.
    • Trasferimento a qualsiasi titolo in altro ospedale.
    • Genitori che non siano in grado di comprendere lo studio che viene proposto o che non possano partecipare in modo affidabile al follow-up telefonico a causa di notevoli barriere linguistiche.
    • Partecipazione a un altro studio con farmaco sperimentale entro i 30 giorni precedenti e durante il presente studio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who temperature goes down, defined by two consecutive body temperature measurements <37.5 ° C performed at 18 and 24 hours after randomization.
    Proporzione di pazienti sfebbrati, definiti in base a due misurazione consecutive della temperatura corporea (TC) <37,5°C eseguite a 18 e 24 ore dalla randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum 72 hours.
    Massimo 72 ore.
    E.5.2Secondary end point(s)
    • Child's pharyngo-tonsillar pain level measured by the FLACC scale between 6 months and 35 months, by the Faces Pain Rating Scale (Wong-Baker scale) between 36 months and 6 years.
    • Proportion of children in need of hospitalization.
    • Length of hospitalization (among inpatients), measured in days.
    • Cumulative incidence of reduction of temperature, calculated from randomization up to the first measurement of body temperature <37.5 ° C confirmed by measurement in the next timepoint.
    • Duration of fever, measured from randomization to the last measurement with temperature > 37.5 °.
    • Livello del dolore faringo-tonsillare del bambino misurato tramite la scala FLACC tra i 6 mesi e i 35 mesi, tramite scala Faces Pain Rating Scale (Scala di Wong-Baker) tra i 36 mesi e i 6 anni.
    • Proporzione di bambini che necessitano un ricovero.
    • Durata del ricovero (tra i ricoverati), misurata in giorni.
    • Incidenza cumulativa di sfebbramento, calcolata dalla randomizzazione fino alla prima misurazione della temperatura corporea (TC) <37,5°C confermata dalla misurazione nel timepoint successivo.
    • Durata della febbre, misurata dalla randomizzazione fino all’ultima misurazione con TC >37,5°.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Maximum 72 hours.
    Massimo 72 ore.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    For pediatric patients the I.C. is provided by the parents or whoever takes their place
    trattandosi di pazienti minori il C. I. è fornito dai genitori o da chi ne fa le veci
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    at the end of this clinical study, patients will be monitorated according to the normal clinical practice.
    al termine della partecipazione allo studio clinico, i pazienti seguiranno il follow up secondo la normale pratica clinica.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-11-22
    P. End of Trial
    P.End of Trial StatusOngoing
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