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    Summary
    EudraCT Number:2017-001087-38
    Sponsor's Protocol Code Number:PI2017_843_0010
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-001087-38
    A.3Full title of the trial
    CLArithromycin versus AZIthromycin in the treatment of Mycobacterium avium complex pulmonary infections:
    A randomized prospective controlled study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLArithromycin versus AZIthromycin in the treatment of Mycobacterium avium complex pulmonary infections:
    A randomized prospective controlled study
    A.3.2Name or abbreviated title of the trial where available
    CLAZI
    CLAZI
    A.4.1Sponsor's protocol code numberPI2017_843_0010
    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 SponsorCHU Amiens-Picardie
    B.1.3.4CountryFrance
    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 supportDirection générale de l'offre de soins
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Amiens-Picardie - DRCI
    B.5.2Functional name of contact pointLucie DESJARDINS
    B.5.3 Address:
    B.5.3.1Street AddressAmiens
    B.5.3.2Town/ cityAmiens
    B.5.3.4CountryFrance
    B.5.4Telephone number33322088383
    B.5.5Fax number33322089645
    B.5.6E-maildesjardins.lucie@chu-amiens.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameClarithromycine
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAzithromycine
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Mycobacterium avium complex pulmonary infections
    Infestion pulmonaire à Mycobacterium avium
    E.1.1.1Medical condition in easily understood language
    Mycobacterium avium complex pulmonary infections
    Infestion pulmonaire à Mycobacterium avium
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    to demonstrate the non-inferiority in term of 6-month sputum conversion rate of azithromycin- to clarithromycin-containing regimen in the Mycobacterium avium complex (MAC) lung disease treatment.
    démontrer la non infériorité en terme de négativation des prélèvements respiratoires à six mois avec un traitement contenant de l’azithromycine en comparaison à un traitement contenant de la clarithromycine dans la prise en charge des infections à Mycobacterium avium complex.
    E.2.2Secondary objectives of the trial
    - To compare azithromycin to clarithromycin containing regimen in the MAC lung disease in terms of
    o Tolerance/safety (especially digestive tolerance, hepatitis, drugs interaction) at different time-points
    o Clinical, radiological improvement at 3, 6, 12 months of treatment
    o 3 months- and 12 months- sputum conversion rate
    o 12 months mortality rate
    - To compare azithromycin and clarithromycin intracellular concentration in plasma and intracellular in circulating mononuclear cells at 1 month and 6 months of treatment, and in hair after 6 months of treatment (nested study)
    - To correlate azithromycin and clarithromycin intracellular concentration in circulating mononuclear cells with:
    o Microbiological success at 6 months
    o Tolerability of treatment.
    - To evaluate the association between MAC species with 6-month conversion rate.
    1/ comparer une association contenant de l’azithromycine à une association contenant de la clarithromycine dans la prise en charge des infections à MAC en terme:
    - de tolérance et de sécurité notamment de tolérance digestive, de risque d’hépatite ou d’interaction médicamenteuse à différents moments,
    - d’amélioration clinique, radiologique à 3, 6 et 12 mois de traitement
    - de négativation des crachats à 3 et 12 mois de traitement,
    - de taux de mortalité à 12 mois,
    2/ comparer les concentrations intracellulaires d’azithromycine et de clarithromycine dans le plasma et dans les cellules mononuclées circulantes à 1 et 6 mois de traitement, et dans les cheveux après 6 mois de traitement,
    3/ corréler les concentrations intracellulaires dans les cellules mononuclées circulantes d’azithromycine et de clarithromycine avec le succès microbiologique à 6 mois et la tolérance du traitement,
    5/ évaluer le taux de négativation des crachats à 6 mois entre les différentes espèces de MAC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Clinical criteria
     Respiratory symptoms and the presence of nodular or cavitary lesion on chest x-ray, confirmed on CT-scan. Lesions may also present in the form of diffuse micronodular syndrome.
    AND
    - Microbiological criteria
     At least two positive cultures for MAC on two sputum specimens obtained on two different days
    AND/OR
     Positive culture for MAC on bronchoalveolar lavage or bronchoscopic aspiration
    AND/OR
     Transbronchial biopsy or surgical lung biopsy presenting histology in favour of mycobacterial infection and positive culture for MAC OR biopsy showing histology compatible with mycobacterial infection and one or more sputum cultures positive for MAC.
    AND
    • Exclusion of other diagnoses on CT scan, bronchoscopy and bacteriological specimens.
    Les patients éligibles sont les patients de 18 ans ou plus ayant un prélèvement positif à Mycobacterium avium complex ayant présenté les critères d’infection ATS/IDSA et nécessitant un traitement. Les critères d’infection ATS/IDSA associent des critères clinico-radiologiques (symptômes respiratoires et présence de lésions nodulaires ou cavitaires sur la radiographie de thorax confirmées sur le scanner, ces lésions peuvent être également à type de syndrome micronodulaire diffus), associées à des critères microbiologiques (au moins deux prélèvements positifs à MAC sur deux examens cytobactériologiques des crachats différentes obtenus à deux jours différents et/ou une culture positive à MAC sur le lavage broncho-alvéolaire ou l’aspiration bronchique et/ou des biopsies transbronchiques positives ou chirurgicales avec une histologie en faveur d’une infection à mycobactérie et une culture positive, ou des biopsies avec histologie compatible avec une infection à mycobactérie et un ou plusieurs prélèvements respiratoires de crachats positifs à MAC) et l’exclusion de tout autre diagnostic sur le scanner thoracique, la fibroscopie et les prélèvements bactériologiques.
    E.4Principal exclusion criteria
    - Known hypersensitivity to one of the molecules of the study (rifampin, ethambutol, azithromycin, clarithromycin)
    - Relapse of MAC lung infection
    - Macrolide resistant stain
    - Treatment with molecules able to interfere with cytochrome P450 that cannot be replaced by another therapeutic class
    - HIV 1 and 2 infection
    - Renal failure with creatinine clearance < 30 mL/min
    - Pregnancy and breastfeeding
    - Contraindications to one of the antibiotic
    - Inability to comply with the requirements of the protocol, especially substance abuse, according to the investigator.
    - Limited life expectancy (e.g 6 months)
    - Patient who has already participated in a clinical trial on medicinal product or treatment strategy for NTM
    - Hypersensibilité connue à l’une des molécules de l’étude (rifampicine, éthambutol, azithromycine, clarithromycine)
    - Rechute d’une infection à MAC,
    - Souche résistante aux macrolides,
    - Traitement qui interagirait avec le cytochrome p450 ne pouvant être remplacé par une autre thérapeutique,
    - Sérologie VIH 1 et 2,
    - Insuffisance rénale avec clearance de la créatinine inférieure à 30 ml/min,
    - Grossesse et allaitement,
    - Contre-indication à l’un des antibiotiques,
    - Impossibilité de suivre le protocole notamment due à une toxicomanie selon l’investigateur,
    - Espérance de vie limitée, inférieure à 6 mois,
    - Patient participant déjà à un essai clinique sur un traitement médical ou une stratégie thérapeutique pour mycobactérie non tuberculeuse.
    E.5 End points
    E.5.1Primary end point(s)
    Culture results of respiratory specimens after 6 months of treatment.
    Résultats de la culture des prélèvements respiratoires après 6 mois après un traitement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    • Safety: digestive toxicity (WHO criteria and Rhodes scale), for hepatitis (cytolysis higher than 3 times normal rate)
    • Clinical improvement on analogic scales
    • Radiological improvement on CT scan criteria
    • 3 and 12 months sputum conversion
    • 12 months outcome (death)
    • 1 and 6 months peak serum and mononuclear cells concentration of azithromycin and clarithromycin and their main metabolites
    • MAC species and 6-month conversion.
    - Pour la tolérance digestive (score OMS et échelle de Rhodes)
    - Pour l’hépatite: cytolyse supérieure à 3 fois la normale,
    - Amélioration clinique évaluée sur des échelles analogiques,
    - Evaluation radiologique évaluée sur des critères scanographiques,
    - Résultats des cultures à 3 et 12 mois des prélèvements respiratoires,
    - Décès ou non après 12 mois de début de traitement,
    - Pic sérique et intracellulaire dans les cellules mononuclées circulantes à 1 mois et 6 mois de traitement pour l’Azithromycine et la Clarithromycine et leurs principaux métabolites,
    - Taux de conversion,
    - Résultats des cultures à 6 mois de traitement selon les espèces de MAC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Azithromycine
    Azithromycin
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned41
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months60
    E.8.9.1In the Member State concerned days
    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: 424
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state424
    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)
    none
    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 Decision2017-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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