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    Summary
    EudraCT Number:2014-005010-31
    Sponsor's Protocol Code Number:INS-212
    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:2015-03-18
    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 number2014-005010-31
    A.3Full title of the trial
    A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Studio multicentrico, randomizzato, in aperto, di amikacina liposomiale per via inalatoria (LAI) in pazienti adulti con infezioni polmonari da micobatteri non tubercolari (MNT) causate da Mycobacterium avium complex (MAC), refrattarie al trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation in Adult Patients who have Nontuberculous Mycobacterial Lung Infections caused by Mycobacterium avium complex that are refractory to treatment
    Studio multicentrico, randomizzato, in aperto, di amikacina liposomiale per via inalatoria (LAI) in pazienti adulti con infezioni polmonari da micobatteri non tubercolari (MNT) causate da Mycobacterium avium complex (MAC), refrattarie al trattamento
    A.4.1Sponsor's protocol code numberINS-212
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02344004
    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 SponsorInsmed Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInsmed Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrime Vigilance Ltd
    B.5.2Functional name of contact pointClinical Trial Info.&PV Call Centre
    B.5.3 Address:
    B.5.3.1Street Address26-28 Frederick Sanger Road, The Surrey Research Park
    B.5.3.2Town/ cityGuildford
    B.5.3.3Post codeGU2 7YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+38514628523
    B.5.6E-mailIgor.Copot@primevigilance.com
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1259
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Amikacin for Inhalation (LAI)
    D.3.4Pharmaceutical form Nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMIKACIN SULFATE
    D.3.9.1CAS number 39831-55-5
    D.3.9.3Other descriptive nameAmikacin Sulfate
    D.3.9.4EV Substance CodeSUB00444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Infezioni polmonari da micobatteri non tubercolari (MNT) causate da Mycobacterium avium complex (MAC), refrattarie al trattamento
    E.1.1.1Medical condition in easily understood language
    Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Infezioni polmonari da micobatteri non tubercolari (MNT) causate da Mycobacterium avium complex (MAC), refrattarie al trattamento
    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 17.1
    E.1.2Level PT
    E.1.2Classification code 10058806
    E.1.2Term Mycobacterium avium complex infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of LAI (590 mg) administered once daily (QD), when added to a multi-drug regimen, for achieving culture conversion (3 consecutive negative sputum cultures) by Month 6 compared to a multi-drug regimen alone
    Valutare l’efficacia di LAI (590 mg) somministrato una volta al giorno (quaque die, QD), quando aggiunto a un regime multifarmaco, per il raggiungimento della conversione colturale (3 espettorati negativi consecutivi) al Mese 6 rispetto a un regime multifarmaco da solo
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of LAI (590 mg) administered QD when added to a multi-drug regimen
    -on the six-minute walk test (6MWT) at Month 6 compared to a multi-drug regimen alone
    -for time to culture conversion compared to a multi-drug regimen alone
    -for achieving sustainability (consecutive negative sputum cultures [with no more than 2 consecutive broth positive cultures] for 12 months on treatment) compared to a multi-drug regimen alone
    -on the durability of treatment success 3 months after the end of total treatment course (negative sputum culture after 3 months off-treatment)
    on the 6MWT at End of Therapy (EOT) compared to a multi-drug regimen alone
    -to evaluate patient-reported symptoms of NTM and change from baseline (Day 1) in quality of life scores on the St. George’s Respiratory Questionnaire (SGRQ) at Month 6
    For exploratory, safety and pharmacokinetic objectives please refer to protocol synopsis on page 5 and 6
    Valutare l’efficacia di LAI 590 mg QD, quando aggiunto a un regime multifarmaco,
    -in relazione ai risultati del test (6MWT) rispetto a un regime multifarmaco da solo
    -in termini di tempo alla conversione colturale vs un regime multifarmaco da solo
    -per l’ottenimento di una risposta sostenuta (espettorati negativi consecutivi [con non più di 2 colture in brodo positive consecutive] per 12 mesi di trattamento) vs un regime multifarmaco da solo
    -in termini di durata del successo del trattamento 3 mesi dopo la fine del ciclo completo di trattamento (espettorato negativo dopo 3 mesi senza trattamento)
    in relazione ai risultati del 6MWT alla EOT vs un regime multifarmaco da solo
    -Valutare i sintomi dell’infezione da MNT e la variazione rispetto al basale (Giorno 1) nei punteggi di qualità della vita al questionario respiratorio SGRQ al Mese 6
    Per gli obiettivi esploratori di sicurezza e di farmacocinetica fare riferimento alle pagine 5 e 6 della sinossi

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. be male or female, 18 years or older
    2. be continually positive for MAC on sputum culture while adhering to a multi-drug treatment regimen for a minimum duration of 6 months which is either ongoing or was stopped no more than 12 months before screening
    3. be diagnosed with MAC NTM lung infection with evidence of nodular bronchiectasis and/or fibrocavitary disease by chest CT
    4. have a MAC lung infection documented by at least 2 positive cultures (MAC or mixed infection with MAC as the dominant species) with at least one obtained within 6 months prior to and/or including screening.. Cultures may be obtained from sputum or bronchoscopy.
    5. have a MAC-positive sputum at screening
    6. be willing to adhere to multi-drug treatment regimen during the course of the study
    7. be able to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for mycobacteriology
    8. female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD)
    9. provide written informed consent before performing any study related procedure
    10. be willing to have serum specimens stored
    11. be able to comply with study medication use, study visits, and study procedures as determined by the investigator
    1.pazienti di entrambi i sessi, di età eguale o superiore a 18 anni;
    2.costante positività per MAC all’esame colturale su espettorato durante trattamento con un regime multifarmaco per un minimo di 6 mesi, ancora in corso o interrotto da non più di 12 mesi prima dello screening;
    3.diagnosi di infezione polmonare da MNT del complesso MAC con evidenza di bronchiectasia nodulare e/o malattia fibro-cavitaria alla TC del torace;
    4.infezione polmonare da MAC documentata da almeno 2 colture positive (per MAC o infezione mista con MAC come specie dominante), di cui almeno una ottenuta nei 6 mesi precedenti lo screening e/o allo screening. Le colture possono essere ottenute da espettorato o campione broncoscopico;
    5.espettorato positivo per MAC allo screening;
    6.disponibilità ad aderire a un regime di trattamento multifarmaco nel corso dello studio;
    7.capacità di fornire almeno 3 ml di espettorato o disponibilità a sottoporsi a induzione con produzione di almeno 3 ml di espettorato per le analisi micobatteriologiche;
    8.disponibilità da parte delle donne potenzialmente fertili ad adottare un metodo accettabile di contraccezione (per esempio: astinenza, metodi ormonali o barriera, sterilizzazione del partner o dispositivo intrauterino [intrauterine device, IUD]);
    9.consenso informato scritto fornito prima dell’esecuzione di qualsiasi procedura correlata allo studio;
    10.consenso alla conservazione dei propri campioni di siero;
    11.capacità di aderire all’uso del medicinale in studio, alle visite dello studio e alle procedure dello studio, secondo quanto stabilito dallo sperimentatore.
    E.4Principal exclusion criteria
    1. patients with cystic fibrosis
    2. patients whose MAC NTM infection is resistant to amikacin (as identified by mutation on RNA sequencing)
    3. patients who are not able to perform the 6MWT
    4. positive pregnancy test or lactation at screening. All women of child bearing potential will be tested. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrheic for at least 1 year), or surgically or naturally sterile.
    5. active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year before screening or anticipated during the study period
    6. active allergic bronchopulmonary mycosis or any other condition requiring chronic systemic corticosteroids at a dose greater than the equivalent of 10 mg/day of prednisone within 3 months before screening
    7. active pulmonary tuberculosis requiring treatment at screening
    8. history of lung transplantation
    9. initiation of chronic therapy (e.g., high-dose ibuprofen, inhaled anti-inflammatory agents including steroids, low dose maintenance steroids, recombinant human deoxyribonuclease [rhDNase]) within 28 days before Day 1.
    10. administration of any investigational drug within 8 weeks before screening
    11. prior exposure to LAI (including clinical study).
    12. known hypersensitivity to aminoglycosides
    13. use of inhaled or systemic aminoglycosides (e.g., tobramycin, amikacin, gentamicin, or streptomycin) within 28 days before Day 1
    14. acquired and primary immunodeficiency syndromes
    15. significant (as determined by the investigator) hearing loss, vestibular dysfunction, or neuromuscular weakness where the potential risk of aminoglycoside toxicity outweighs the potential benefit
    16. aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 times the upper limit of normal (ULN) at screening
    17. absolute neutrophil count ≤500/μL at screening
    18. serum creatinine >2 times ULN at screening
    19. current alcohol, medication or illicit drug abuse
    20. any condition that, in the opinion of the Investigator, interferes with ability to safely complete the study or adhere to study requirements
    21. persons who have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    1.pazienti con fibrosi cistica;
    2.pazienti la cui infezione da MNT del complesso MAC è resistente ad amikacina (come stabilito in base al riscontro di mutazione al sequenziamento dell’RNA);
    3.pazienti non in grado di eseguire il 6MWT;
    4.test di gravidanza positivo o paziente in fase di allattamento allo screening. Tutte le donne potenzialmente fertili saranno sottoposte a test di gravidanza. Sono definite non potenzialmente fertili le donne in età postmenopausale (ovvero, con amenorrea da almeno 1 anno), oppure chirurgicamente o naturalmente sterili;
    5.malignità polmonare attiva (primitiva o metastatica) o qualsiasi malignità con necessità di trattamento chemioterapico o radioterapico nell’anno precedente lo screening o prevista nel periodo dello studio;
    6.micosi broncopolmonare allergica in fase attiva o qualsiasi altra condizione che richieda una terapia cronica con corticosteroidi per via sistemica a una dose superiore all’equivalente di 10 mg/die di prednisone nei 3 mesi precedenti lo screening;
    7.tubercolosi polmonare attiva con necessità di trattamento allo screening;
    8.anamnesi di trapianto polmonare;
    9.avvio di una terapia cronica (per esempio, ibuprofene ad alta dose, agenti antinfiammatori per via inalatoria, inclusi agenti steroidei, steroidi di mantenimento a bassa dose, desossiribonucleasi umana ricombinante [recombinant human deoxyribonuclease, rhDNase]) nei 28 giorni precedenti il Giorno 1;
    10.somministrazione di farmaci sperimentali nelle 8 settimane precedenti lo screening;
    11.pregressa esposizione a LAI (anche all’interno di uno studio clinico);
    12.ipersensibilità nota agli aminoglicosidi;
    13.utilizzo di aminoglicosidi (per esempio, tobramicina, amikacina, gentamicina o streptomicina) per via inalatoria o sistemica nei 28 giorni precedenti il Giorno 1;
    14.sindromi da immunodeficienza acquisita e primaria;
    15.perdita dell’udito significativa (come stabilito dallo sperimentatore), disfunzione vestibolare o debolezza neuromuscolare, tali per cui il potenziale rischio di tossicità da aminoglicosidi ecceda il beneficio potenziale;
    16.livelli di aspartato aminotransferasi o alanina aminotransferasi ≥ 3 volte il limite superiore della normalità (upper limit of normal, ULN) o bilirubina totale ≥ 2 volte il limite superiore della normalità (ULN) allo screening;
    17.conta assoluta dei neutrofili allo screening ≤500/μl;
    18.creatinina sierica allo screening > 2 volte l’ULN;
    19.attuale abuso di alcol, medicinali o sostanze illecite;
    20.qualsiasi condizione che, a giudizio dello sperimentatore, interferisca con la capacità di portare a termine lo studio in modo sicuro o di aderire ai requisiti dello studio;
    21.persone affidate a un istituto in virtù di un ordine emesso da un’autorità giudiziaria o amministrativa.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjectsachieving culture conversion (3 consecutive negative sputum cultures collected monthly without relapse or recurrence) by Month 6 in the LAI arm compared to multi-drug regimen alone.
    L’endpoint primario è la percentuale di soggetti che ottiene la conversione dell’esame colturale (3 espettorati negativi consecutivi raccolti mensilmente senza recidiva o ricorrenza) al Mese 6 nel braccio di trattamento con LAI rispetto a un regime multiterapia da solo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of primary endpoint will be done at Month 8
    La valutazione dell’endpoint primario verrà effettuata al Mese 8
    E.5.2Secondary end point(s)
    SECONDARY EFFICACY ENDPOINTS
    1. Change in 6MWT distance at Month 6 in the LAI arm compared to a multi-drug regimen alone
    2. Time to culture conversion in the LAI arm compared to a multi-drug regimen alone at Month 6
    3. Proportion of subjects achieving culture conversion with sustainability at the EOT in the LAI arm compared to a multi-drug regimen alone
    4. Proportion of subjects achieving culture conversion with durability at the EOS (3 months off treatment) in the LAI arm compared to a multi-drug regimen alone in all evaluable subjects
    5. Change in 6MWT distance at EOT in the LAI arm compared to a multi-drug regimen alone
    6. The mean change from baseline (Day 1) at Month 6 in the SGRQ.

    EXPLORATORY ENDPOINTS
    1. Change in 6MWT distance at Month 8 in the LAI arm compared to a multi-drug regimen alone
    2. Change in 6MWT distance at EOS in the LAI arm compared to a multi-drug regimen alone
    3. The mean change from baseline (Day 1) at Month 6 in the SGRQ – Part 2 (Activities of Daily Livings)
    4. The mean change from baseline (Day 1) at EOT in the EQ-5D
    5. Proportion of subjects who develop a new strain of MAC in the LAI arm compared to multi-drug regimen alone
    6. Radiological changes in CT Scan at EOT in the LAI arm compared to multi-drug regimen alone, where appropriate
    7. Mortality at EOS.
    1.Variazione al Mese 6 nella distanza percorsa al 6MWT nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo
    2.Tempo alla conversione dell’esame colturale nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo al Mese 6
    3.Percentuale di soggetti che ottiene una conversione dell’esame colturale con mantenimento della risposta all’EOT nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo
    4.Percentuale di soggetti che ottiene una conversione dell’esame colturale con durabilità all’EOS (3 mesi senza trattamento) nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo in tutti i soggetti valutabili
    5.Variazione nella distanza percorsa al 6MWT all’EOT nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo
    6.Variazione media dal basale (Giorno 1) al Mese 6 nei punteggi del SGRQ.
    ENDPOINT ESPLORATIVI
    1.Variazione nella distanza percorsa al 6MWT al Mese 8 nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo
    2.Variazione nella distanza percorsa al 6MWT all’EOS nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo
    3.Variazione media dal basale (Giorno 1) al Mese 6 nei punteggi del SGRQ – Parte 2 (Attività della vita quotidiana)
    4.Variazione media dal basale (Giorno 1) all’EOT nei punteggi dell’EQ-5D
    5.Percentuale di soggetti che sviluppa un nuovo ceppo di MAC nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo
    6.Modifiche radiologiche dell’esame TC all’EOT nel braccio di trattamento con LAI rispetto a un regime multifarmaco da solo, ove appropriato
    7.Mortalità all’EOS
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline till end of study
    Dal basale fino alla fine dello studio
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Australia
    Austria
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Netherlands
    New Zealand
    Poland
    Spain
    United Kingdom
    United States
    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
    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 months7
    E.8.9.1In the Member State concerned days7
    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 days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 351
    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 Month 8, all non-converters will be eligible to enter a separate open-label study. All converters will continue on the same treatment regimen until they complete a total of 12 months beginning from the first negative culture.
    The investigator will discuss treatment options with each subjects.
    Al mese 8 tutti i soggetti senza conversione saranno eleggibili all’ingresso in uno studio in aperto. Tutti i soggetti con conversione proseguiranno il regime di trattamento a cui sono stati randomizzati per 12 mesi a partire dalla prima coltura negativa che definisce l’avvenuta conversione.
    Il Ricercatore Principale discuterà le opzioni di trattamento con ogni soggetto.
    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 Decision2015-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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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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