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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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:2021-005097-25
    Sponsor's Protocol Code Number:KIDS-STEP
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-04-12
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-005097-25
    A.3Full title of the trial
    A randomised placebo-controlled multi-centre effectiveness trial of adjunct betamethasone
    therapy in hospitalised children with community acquired pneumonia (CAP)
    Eine randomisierte kontrollierte Studie zum zusätzlichen Einsatz von Kortison bei hospitalisierten Kindern mit ambulant erworbenen Infektionen der unteren Atemwege
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Betamethasone therapy in hospitalised children with community acquired pneumonia (CAP).
    Betamethason-Therapie bei hospitalisierten Kindern mit ambulant erworbener Pneumonie (CAP).
    A.3.2Name or abbreviated title of the trial where available
    KIDS-STEP
    A.4.1Sponsor's protocol code numberKIDS-STEP
    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 SponsorUniversitätskinderspital beider Basel (UKBB)
    B.1.3.4CountrySwitzerland
    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 supportSwiss National Science Foundation
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Düsseldorf
    B.5.2Functional name of contact pointKlinik für Pädiatrie, Neonatologie
    B.5.3 Address:
    B.5.3.1Street AddressMoorenstr. 5
    B.5.3.2Town/ cityDüsseldorf
    B.5.3.3Post code40225
    B.5.3.4CountryGermany
    B.5.4Telephone number+49211811 8297
    B.5.6E-maildirk.schramm@med.uni-duesseldorf.de
    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 Celestamine
    D.2.1.1.2Name of the Marketing Authorisation holderOrganon Healthcare GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCelestamine®
    D.3.4Pharmaceutical form Oral liquid
    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 INNBETAMETHASONE
    D.3.9.1CAS number 378-44-9
    D.3.9.4EV Substance CodeSUB05797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 placeboOral liquid
    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
    Children with community acquired pneumonia (CAP).
    Kinder mit ambulant erworbener Pneumonie (CAP).
    E.1.1.1Medical condition in easily understood language
    Children with lung infections.
    Kinder mit einer Lungenentzündung.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to concurrently evaluate whether adjunct treatment with corticosteroids in children hospitalised with CAP is more effective in terms of the proportion of children reaching clinical stability and whether such adjunct treatment is no worse in terms of CAP relapse. The primary objective of this study therefore is to concurrently evaluate whether treatment of children hospitalised for CAP with oral betamethasone is superior to placebo in terms of time to clinical stability (defined as resolution of vital sign abnormalities in room air) after hospitalization: and whether inpatient treatment of childhood CAP with oral betamethasone is non-inferior to placebo in terms of the proportion of children with CAP-related readmission to hospital up to 28 days after randomisation.
    E.2.2Secondary objectives of the trial
    Secondary objectives include the evaluation of effects of oral betamethasone treatment (versus placebo) in children hospitalised for CAP on:
    - duration of primary hospital stay;
    - severity and duration of CAP symptoms;
    - intensive care unit admissions;
    - mortality;
    - rate and severity of solicited clinical side effects;
    - rate of serious adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - At least 6 months of age and less than 14 years of age
    - Body weight between 5 kg and 45 kg
    - Admission to hospital (i.e. assignment of an inpatient case number or receipt of in-hospital
    treatment in a designated short stay unit)
    - Clinical diagnosis of CAP (see below)
    - Parent and/or child (as age-appropriate) willing to accept all possible randomised allocations
    and to be contacted by telephone weekly up to and including at 4 weeks after randomisation
    - Informed consent form for trial participation signed by parent
    The following constellation of signs and symptoms will be taken to indicate a clinical diagnosis of CAP:
    -Temperature >= 38°C measured by any method or history of fever in last 48 hours reported by
    parents
    AND at least two of the following signs and/or symptoms:
    - Presence of cough (observed or reported in last 72 to 96 hours);
    - Increased age-specific respiratory rate as defined by Paediatric Advanced Life Support
    (PALS) guidelines during assessment in PED (first or second triage or clinical examination);
    - Hypoxaemia <92% in room air as measured by transcutaneous oxygen monitoring;
    - Signs of laboured/ difficult breathing, including nasal flaring, chest retractions, grunting,
    abdominal breathing and shortness of breath;
    - Clinical signs of lobar pneumonia including focal dullness to percussion, focal reduced breath
    sounds, crackles with asymmetry.
    - Children younger than 6 month of age will not be included as a high proportion of acute lower
    respiratory tract infections affecting infants are episodes of bronchiolitis which are known not to benefit from corticosteroid treatment
    E.4Principal exclusion criteria
    - Presence of local complications (empyema, pleural effusion with clinically identified need for
    drainage, pneumothorax, and pulmonary abscess)
    - Chronic underlying disease associated with an increased risk of very severe CAP or CAP of
    unusual aetiology, such as sickle cell disease, primary or secondary immunodeficiency,
    chronic lung disease and cystic fibrosis
    - Bilateral wheezing without focal chest signs AND clinical indication for primary administration
    of steroids (most likely to represent respiratory tract infection affecting the medium airways, i.e.
    not pneumonia)
    - Admission to hospital with a primary clinical diagnosis of bronchiolitis
    - Inability to tolerate oral medication
    - Documented allergy or any other known contraindication to any trial medication
    - Subacute or chronic conditions requiring higher betamethasone equivalent or known primary
    or secondary adrenal insufficiency
    - Known diabetes mellitus (type 1)
    - Hospitalisation within the last two weeks preceding current admission with the possibility that
    pneumonia could be hospital-acquired or healthcare-associated
    - Completion of a course of systemic corticosteroids within 2 weeks from enrolment for courses
    of >5 days
    - Transfer for any reason to a non-participating hospital directly from the paediatric emergency
    department
    - Parents are unlikely to be able to reliably participate in telephone follow-up because of
    significant language barriers
    - Participation in another study with an investigational drug within the 30 days preceding and during the present study
    - Previous enrolment into the current study
    - Enrolment of the investigator, his/her family members, and other dependent persons.
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary outcomes:
    (i) The time to clinical stability after randomisation in the active treated group (oral betamethasone for up to 2 days) as compared to the control group (placebo) will be one primary outcome.
    (ii) The proportion of children with CAP-related readmission within 28 days after randomisation comparing oral betamethasone and placebo will be the co-primary outcome.

    Regarding (i): Clinical stability will be defined as the attending clinician assessing the child as being ready for hospital discharge or recorded normal respiratory rate, heart rate and oxygen saturation. Children discharged will be assumed to be clinically stable at discharge. For respiratory rate and heart rate, at least two consecutive age-related normal values as specified in the American Heart Association Accredited Pediatric Advance Life Support documentation will be taken to indicate stability. Oxygen saturation in room air of 92% or above will be considered normal.

    Rationale: Clinical stability is relevant to patients and their families as a prerequisite for hospital discharge, and can have considerable socioeconomic impacts on the child and parents by allowing a return to normal activity for the whole family. A rapid recovery with no respiratory problems and no need for supplemental oxygen represents directly patient-relevant components of this outcome.
    The average length of stay (LOS) of hospitalised children with CAP is 2 days and by 3-4 days more than 75% of children with this diagnosis have been discharged home 35, 36. This reflects the relatively rapid recovery of children with CAP compared to adults. The outcome “length of stay” is expected to be closely correlated to the primary endpoint and will be assessed as a secondary endpoint. It has been discarded as a primary outcome as it is likely to vary locally and will be influenced by a range of administrative and other non-clinical factors. Nonetheless, a difference in time to stability is expected to be clinically and patient- relevant if it results in earlier discharge from hospital. Therefore, following a simulation study using a survey of admission and discharge times for CAP at the trial sites and time-to-stability data from an early subset of trial participants, a difference of 18 hours in median time to stability between the trial arms was selected as the threshold to allow postulation of a relevant effect.

    Regarding (ii): CAP-related readmissions will be recorded by active surveillance at participating centres and in addition will be identified through parental reporting.

    Rationale: In clinical practice, adjunct oral steroids are likely to be useful if the clinical benefits (higher likelihood of clinical stability at an early stage with the potential to be discharged from hospital earlier) outweigh any potential unwanted effects, such as clinically relevant CAP recurrence requiring readmission to hospital. Overall, a small increase in CAP recurrence may be acceptable assuming a low NNT for clinical stability. 28-day antibiotic retreatment rates for adults and children with lower respiratory tract infections prescribed antibiotics in the community setting have been described to be as high as 17% in the UK (Currie, 2014), but published Swiss hospital data for readmission rates are lacking.
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of study; interim analysis (blinded sample size re-estimation will be performed)
    E.5.2Secondary end point(s)
    •Time to resolution of vital sign abnormalities in hours. (with normalisation defined as above)
    •Time to hospital discharge after index hospitalisation in days.
    •Total duration of hospitalisation in days up to 28 days after randomisation.
    •Proportion of children (re)treated with antibiotics after discharge for any reason at 28 days after randomisation.
    •Proportion of children admitted to intensive care during the initial hospitalisation and up to 28 days after randomisation.
    •Proportion of children experiencing solicited side effects of the trial treatment and/or serious adverse events.
    •Duration of individual moderate-severe CAP symptoms in days, including cough, poor appetite and reduced activity assessed by a standardised and validated questionnaire to be completed by parents of participating children at week 1, 2 and 3 after randomisation.
    •Mortality up to 28 days after randomisation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of study; interim analysis (blinded sample size re-estimation will be performed)
    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 Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number of subjects for this age range: 200
    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: 100
    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.1.3Elderly (>=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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    minor subjects
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 510
    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)
    Subjects will be treated according to local clinical routine after study end.
    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 Decision2022-08-09
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-03-26
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