Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002980-25
    Sponsor's Protocol Code Number:PRESERV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-10-07
    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 number2018-002980-25
    A.3Full title of the trial
    Randomized, multicenter, open-label study on PREvention of respiratory SEquelae of RSV bronchiolitis in preterm babies (PRESERV)
    Studio randomizzato, multicentrico, in aperto, sulla prevenzione delle sequele respiratorie da bronchiolite dovuta al virus respiratorio sinciziale (VRS), nei bambini nati prematuri (PRESERV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on prevention of respiratory consequences related to bronchiolitis caused by respiratory sincizial virus (RSV) in preterm babies
    Studio sulla prevenzione delle conseguenze respiratorie della bronchiolite dovuta al virus respiratorio sinciziale (VRS) nei bambini nati prematuri
    A.3.2Name or abbreviated title of the trial where available
    Prevention of respiratory consequences due to viral bronchiolitis in preterm babies
    Prevenzione conseguenze respiratorie da bronchiolite virale in neonati pretermine
    A.4.1Sponsor's protocol code numberPRESERV
    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 SponsorOSP.DEGLI INFERMI DI BIELLA
    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 supportAIFA - Italian Medicines Agency
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale degli Infermi di Ponderano (Biella)
    B.5.2Functional name of contact pointDipartimento Materno Infantile
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Ponderanesi 2
    B.5.3.2Town/ cityPonderano
    B.5.3.3Post code13875
    B.5.3.4CountryItaly
    B.5.4Telephone number01515156905
    B.5.6E-mailpaolo.manzoni@aslbi.piemonte.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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namepalivizumab
    D.3.2Product code [non disponibile]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpalivizumab
    D.3.9.1CAS number 188039-54-5
    D.3.9.2Current sponsor codenon applicabile
    D.3.9.4EV Substance CodeSUB03606MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Respiratory sincizial virus (RSV) bronchiolitis
    bronchiolite causata dal virus respiratorio sinciziale (VRS)
    E.1.1.1Medical condition in easily understood language
    viral bronchiolitis
    bronchiolite virale
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10038718
    E.1.2Term Respiratory syncytial virus bronchiolitis
    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 compare the incidence rate of overall respiratory morbidity in otherwise healthy (neonate who does not display any major short-or long-term morbidity related to prematurity) preterm babies 29 +0 - 35+6 wGA exposed to prophylaxis with palivizumab (Group A) vs. infants 29+0 - 35+6 wGA NOT exposed to prophylaxis with palivizumab (Group B).
    Confrontare il tasso di incidenza della morbidità respiratoria complessiva in neonati sani (che non presentano alcuna comorbidità maggiore, nel breve e lungo termine, correlata alla prematurità), nati pretermine tra la 29+0 e la 35+6 settimana gestazionale e di età uguale o inferiore ai 6 mesi, sottoposti a profilassi con palivizumab (Gruppo A) rispetto a quelli non sottoposti a profilassi con palivizumab (Gruppo B).
    E.2.2Secondary objectives of the trial
    To evaluate the difference of RSV-related hospitalization due to low respiratory tract infection during the first RSV-season (November 1st - March31th) between Group A and Group B
    To evaluate direct and indirect costs related to respiratory sequelae in both groups. The following information for an accurate cost evaluation will be collected: length of hospitalizations; need for Mechanical Ventilation and other support therapies; Intensive Care Unit admission and length of stay; medical specialistic visits; drugs (type, dosages and therapy duration); diagnostic exams, loss of working days for parents due to child illness.
    Valutare la differenza nelle ospedalizzazioni correlate a VRS e dovute a infezioni del tratto respiratorio inferiore durante la stagione epidemica, nel Gruppo A di pazienti trattato con palivizumab e nel Gruppo B non trattato durante la stagione epidemica (1 novembre - 31 marzo).
    Valutare i costi diretti e indiretti correlati alle sequele respiratorie in entrambi i gruppi di pazienti. Le seguenti informazioni saranno raccolte per un'accurata valutazione dei costi: durata delle ospedalizzazioni; necessità di ventilazione meccanica e di altre terapie di supporto; ricovero in unità di cura intensiva e durata del ricovero; visite mediche specialistiche; farmaci (tipo, dosaggio e durata della terapia); esami diagnostici; perdita di giorni lavorati per i genitori a causa della malattia del bambino.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Otherwise healthy (neonate who does not display any major short-or long-term morbidity related to prematurity) preterm Infants 29+0 - 35+6 wGA (male and female);
    - younger than 6 months of age at the beginning of the RSV season (November 1st);
    · written IC obtained from parents/legal guardian.
    - Neonati sani (che non presentano alcuna comorbidità maggiore nel breve e lungo termine correlata alla prematurità), maschi e femmine, nati prematuri tra la 29+0 e la 35+6 settimana gestazionale;
    - età inferiore o uguale ai 6 mesi all’inizio della stagione epidemica (convenzionalmente stabilita 1 novembre);
    - modulo di Consenso Informato firmato da genitori/rappresentante legale autorizzato del paziente.
    E.4Principal exclusion criteria
    - Children HIV+;
    - children with neoplasia;
    - children with a known cardiac anomaly;
    - children with Down syndrome;
    - children with severe congenital disorders;
    - children who had physician-diagnosed wheeze before the start of the RSV season;
    - high risk for severe course of RSV infection: children with Bronchopulmonary Dysplasia, children with neuromuscular impairment, children with cystic fibrosis, children with diaphragmatic hernia and other severe congenital respiratory disorders
    - documented hypersensitivity to the drug or to any of its excipients, or to other humanized monoclonal antibodies.
    - Neonati affetti da HIV (Human Immunodeficiency Virus);
    - neonati affetti da neoplasia;
    - neonati affetti da anomalie cardiache già diagnosticate in precedenza;
    - neonati affetti da sindrome di Down;
    - neonati affetti disordini severi congeniti;
    - neonati con respiro sibilante diagnosticato dal medico prima della stagione epidemica;
    - alto rischio di decorso severo dell’infezione da VRS: bambini con displasia polmonare, bambini con problemi neuromuscolari, bambini con fibrosi cistica, bambini con ernia diaframmatica e altri disturbi respiratori congeniti severi;
    - documentata ipersensibilità al principio attivo o ad uno qualsiasi dei suoi eccipienti, o ad altri anticorpi monoclonali umanizzati.
    E.5 End points
    E.5.1Primary end point(s)
    Overall respiratory morbidity (composite primary endpoint), whose definition is:
    a) LRTIs by any pathogen (including, but not limited to, RSV) +
    b) recurrent wheezing (quantified as presence of wheezing days and/or need for use of antiwheezing drugs) +/- asthma
    Morbidità respiratoria complessiva (endpoint composito primario) definita come:
    - infezione del tratto respiratorio inferiore causata da qualsiasi agente patogeno (compreso il virus respiratorio sinciziale – VRS)
    - respiro sibilante ricorrente (quantificato come giorni con presenza di respiro sibilante e/o necessità di impiego di medicinali per trattare l’evento) con o senza asma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 mesi
    E.5.2Secondary end point(s)
    Difference of RSV-related hospitalization due to low respiratory tract infection during the first RSV-season (November 1st - March31th) between Group A (treated with palivizumab) and Group B (not treated).; Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to:
    a. length of hospitalizations (days);
    b. mechanical ventilation and other support therapies (type, number, duration);
    c. Intensive Care Unit admission and length of stay (days);
    d. outpatient visits (type and number of specialistic visits);
    f. drugs (type, dosages and therapy duration);
    g. diagnostic tests (type and number).
    Costs for resources used will be calculated using National Health Service tariffs.; Indirect costs in terms of loss of working days for parents due to child illness.
    Differenza di ospedalizzazioni correlate a VRS e dovute a infezioni del tratto respiratorio inferiore durante la stagione epidemica (1 novembre - 31 marzo), tra il gruppo A di pazienti trattato con palivizumab e il gruppo B non trattato.; Costi diretti in termini di differenza nel consumo di risorse sanitarie usate rispettivamente dal gruppo di pazienti trattato con palivizumab e dal gruppo non trattato, e correlate a:
    - a. durata delle ospedalizzazioni (giorni);
    - b. ventilazione meccanica e altre terapie di supporto (tipo, numero, durata);
    - c. ricovero in Unità di Cura Intensiva e durata del ricovero (giorni);
    - d. visite specialistiche (tipo e numero);
    - f. farmaci (tipo, dosaggio e durata della terapia);
    - g. test diagnostici (tipo e numero).
    I costi delle risorse utilizzate verranno calcolati utilizzando le tariffe del Servizio Sanitario Nazionale.; Costi indiretti (in termini di giorni di lavoro persi dai genitori a causa della malattia del bambino) correlati alle sequele respiratorie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months; 18 months; 18 months
    18 mesi; 18 mesi; 18 mesi
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Nessuna terapia o plaebo
    no therapy or placebo
    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 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 years0
    E.8.9.1In the Member State concerned months29
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months29
    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) Yes
    F.1.1.2.1Number of subjects for this age range: 760
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 160
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 600
    F.1.1.5Children (2-11years) No
    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
    Newborns until 6 months of age
    Neonati fino ai 6 mesi di età
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state760
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 760
    F.4.2.2In the whole clinical trial 760
    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)
    No treatment or care program are planned, since the study IMP will be administered only 5 times and it is a preventive therapy.
    Non è prevista un programma di trattamento al termine dello studio. Trattandosi di una terapia preventiva sono previste solo 5 somministrazioni di IMP.
    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 Decision2020-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Oct 31 08:27:16 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA