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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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:2015-003881-96
    Sponsor's Protocol Code Number:EPAFC
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-003881-96
    A.3Full title of the trial
    Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways.
    Studio randomizzato multicentrico sull' eradicazione di Pseudomonas aeruginosa in pazienti con fibrosi cistica: confronto tra il trattamento eradicante classico e il trattamento classico associato con la terapia antibiotica delle alte vie respiratorie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosis
    Studio clinico per confrontare due trattamenti per l’eradicazione di Pseudomonas aeruginosa in pazienti con fibrosi cistica
    A.3.2Name or abbreviated title of the trial where available
    Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with
    Studio clinico per la valutazione di due diversi protocolli di eradicazione di Pseudomonas aeruginos
    A.4.1Sponsor's protocol code numberEPAFC
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
    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 supportFONDAZIONE FIBROSI CISTICA ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO UNIVERSITARIA MEYER
    B.5.2Functional name of contact pointFIBROSI CISTICA
    B.5.3 Address:
    B.5.3.1Street AddressVIALE PIERACCINI 24
    B.5.3.2Town/ cityFIRENZE
    B.5.3.3Post code50139
    B.5.3.4CountryItaly
    B.5.4Telephone number0555662474
    B.5.5Fax number0555662470
    B.5.6E-mailgiovanni.taccetti@meyer.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.2.1.1.1Trade name COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA S.P.A.
    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 nameNA
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLISTIMETATO SODICO
    D.3.9.1CAS number 1264-72-8
    D.3.9.2Current sponsor codeCOLISTINA
    D.3.9.3Other descriptive nameCOLISTIN
    D.3.9.4EV Substance CodeSUB01429MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cystic fibrosis
    fibrosi cistica
    E.1.1.1Medical condition in easily understood language
    cystic fibrosis
    fibrosi cistica
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of the classic protocol together with nasal lavage using colistin (arm B) versus the classic eradication protocol used up until now (arm A), in terms of eradication of P aeruginosa in the the lower airways of CF patients
    Valutare l’efficacia del trattamento standard associato a lavaggi nasali con colistina (trattamento B) rispetto al solo trattamento standard (trattamento A) in termini di eradicazione dello P. aeruginosa a livello delle vie aeree inferiori.


    E.2.2Secondary objectives of the trial
    - Evaluation of the efficacy of medical treatment B on P. aeruginosa eradication in the upper airways
    - Evaluation of correlation between the presence of P. aeruginosa in the upper airways and successive lower respiratory infections
    - Evaluation of the role of the microbiological status of the paranasal sinuses in the development of P. aeruginosa infection
    - Evaluation of the evolution of P. aeruginosa adaptations in the respiratory
    - Valutare l’efficacia del trattamento B a livello a livello delle vie aeree superiori
    - Valutare la correlazione fra vie aeree superiori e inferiori in termini di presenza di P. aeruginosa
    - Determinare lo status microbiologico dei seni paranasali al momento dell’isolamento di P. aeruginosa nelle vie aeree inferiori
    - Valutare l’adattamento e l’evoluzione di P. aeruginosa nelle vie aeree di pazienti affetti da FC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - CF patients older than 4 years with initial (first or intermittent) P. aeruginosa infection of the lower airways. The infection is defined according to Leeds’ criteria.
    - Patients who make regular (quarterly) visit and undergo regular (quarterly) microbiological follow-up
    - No clinical signs or symptoms of respiratory exacerbation
    - Informed Consent
    - Female patients with reproductive potential must agree to use effective contraception during the study period
    - Pazienti con diagnosi di FC di età superiore a 4 anni con iniziale (prima o intermittente) infezione da P.aeruginosa delle vie aeree inferiori, stabilita attraverso l’analisi dell’espettorato o tampone faringeo, secondo la classificazione di Leeds
    - Pazienti che si presentano regolarmente alle 4 visite di controllo annuali durante le quali viene svolto il follow-up microbiologico
    - Assenza di segni o sintomi di esacerbazione respiratoria
    - Ottenimento del consenso informato
    - Donne in età fertile che adottano appropriate misure anticoncezionali
    E.4Principal exclusion criteria
    - Chronic infection by P. aeruginosa (according to the Leeds’ definition).
    - Chronic infection by other non-fermentative Gram- negative bacteria.
    - CF patients who, concurrently with P. aeruginosa infection, show evidence of respiratory exacerbation, which renders treatment with intravenous antibiotics indispensable.
    - History of aminoglycoside, aztreonam lisine or colistin hypersensitivity.
    - Adverse reaction to study antibiotics.
    - History of hypersensitivity or adverse reaction to ciprofloxacin or other fluoroquinolones.
    - History of persistent, unresolved hearing loss not associated with middle ear disease or an abnormal tympanogram.
    - Abnormal kidney function at study entry (defined as a serum creatinine level more than 1.5 times the upper normal limit for the participant’s age).
    - Abnormal liver function test results at study entry, defined as ALT and/ or AST levels more than twice the upper limit of the normal range.
    - Use of any investigational drug within 30 days of study entry.
    - Chronic macrolide use in the 3 months prior to study entry.
    - Presence of a condition or abnormality that would compromise the participant’s safety or the quality of the study data, in the opinion of the investigator.
    - Pregnancy
    - Breastfeeding
    - Infezione cronica da P.aeruginosa (secondo la definizione di Leeds)
    - Infezione cronica da altri batteri non- fermentativi Gram-negativi
    - Pazienti FC con infezione P. aeruginosa in atto che mostrano evidenza di esacerbazione respiratoria che rende necessario il trattamento con terapia antibiotica endovenosa
    - Storia di ipersensibilità ad aminoglicosidici, aztreonam lisina o colistina
    ¿ Storia di reazioni avverse gravi agli antibiotici impiegati nello studio
    - Storia di ipersensibilità o reazioni avverse alla ciprofloxacina o ad altri fluoroquinolonici.
    - Storia di persistente perdita dell'udito non risolvibile associata a malattia dell'orecchio medio o ad un anormale timpanogramma.
    - Funzione renale alterata all'ingresso dello studio, definita con livelli di creatinine serica 1.5 volte superiori al limite superiore della norma per l’età del paziente
    - Funzione epatica alterata all'ingresso dello studio, definita con livelli di AST/ALT due volte superiori al limite della norma
    - Utilizzo di un qualsiasi altro farmaco oggetto di studio 30 giorni dall'inizio dell'ingresso nello studio
    - Uso cronico di macrolidi nei 3 mesi prima dell'ingresso nello studio
    - Presenza di altra condizione di anormalità, a discrezionalità del ricercatore, che potrebbe compromettere la sicurezza del partecipante.
    - Gravidanza presunta o accertata
    - Donne in allattamento
    E.5 End points
    E.5.1Primary end point(s)
    - Difference between the 2 groups in terms of proportion of eradication of P. aeruginosa in the lower airways. Eradication is defined as at least 3 negative cultures performed over a period of 6 months.
    - Differenza nella proporzione di eradicazione di P. aeruginosa dalle vie aeree inferiori nei due gruppi, definita sulla base di standard internazionali (3 esami colturali consecutivi, tampone faringeo o escreato, negativi per P. aeruginosa nell'arco di 6 mesi).

    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    - proportion of eradication of P. aeruginosa in the upper airways. P. aeruginosa eradication is defined as at least 3 negative cultures performed over a period of 6 months.
    - Proportion of patients with P. aeruginosa isolation from upper and lower respiratory tracts.
    - P. aeruginosa isolation from upper respiratory tracts after the nasal colistin irrigations
    - phenotypic and genotypic features of P. aeruginosa
    - proporzione di pazienti con eradicazione di P. aeruginosa dalle vie aeree superiori definita sulla base di standard internazionali (3 esami colturali consecutivi, lavaggio nasale, negativi per P. aeruginosa nell'arco di 6 mesi)
    - Proporzione di pazienti che presentano P. aeruginosa sia nelle vie aeree superiori (lavaggio nasale) che inferiori (escreato/tampone faringeo)
    - Isolamento di P. aeruginosa dalle prime vie aeree dopo lavaggio nasale effettuato durante 3 visite di controllo ai pazienti di entrambi i gruppi
    - genotipizzazione e fenotipizzazione di P. aeruginosa
    E.5.2.1Timepoint(s) of evaluation of this end point
    All: 6 months
    Phenotypic and genotypic features of P. aeruginosa: 24 months
    Tutti: 6 mesi
    Genotipizzazione e fenotipizzazione di P. aeruginosa: 24 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 Yes
    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 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
    Terapia standard per l'eradicazione di P. aeruginosa
    Standard therapy for P. aeruginosa eradication
    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 concerned15
    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
    Or in case interim analysis show highier efficacy of the experimental treatment
    LVLS
    Oppure se le interim analysis dimostrano una maggiore efficacia del trattamento in sperimentazione.
    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 months7
    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 months7
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    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) Yes
    F.1.2.1Number of subjects for this age range: 37
    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 Yes
    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 state112
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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)
    nessuno
    nessuno
    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 Decision2016-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-17
    P. End of Trial
    P.End of Trial StatusCompleted
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