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    Summary
    EudraCT Number:2018-000741-39
    Sponsor's Protocol Code Number:6996
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-09-20
    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 number2018-000741-39
    A.3Full title of the trial
    EFFECT OF AZITHROMYCIN ON THE PROPORTION OF FAILURES OF SEVERE PERIODONTITIS NON-SURGICAL TREATMENTS : A RANDOMIZED, DOUBLE-BLIND VERSUS PLACEBO STUDY
    EFFET DE L'AZITHROMYCINE SUR LA PROPORTION D'ECHECS DES TRAITEMENTS NON-CHIRURGICAUX DES PARODONTITES SEVERES : ETUDE RANDOMISEE, EN DOUBLE AVEUGLE VERSUS PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF AZITHROMYCIN ON THE PROPORTION OF FAILURES OF SEVERE PERIODONTITIS NON-SURGICAL TREATMENTS : A RANDOMIZED, DOUBLE-BLIND VERSUS PLACEBO STUDY
    EFFET DE L'AZITHROMYCINE SUR LA PROPORTION D'ECHECS DES TRAITEMENTS NON-CHIRURGICAUX DES PARODONTITES SEVERES : ETUDE RANDOMISEE, EN DOUBLE AVEUGLE VERSUS PLACEBO
    A.3.2Name or abbreviated title of the trial where available
    AZITHROPARO
    AZITHROPARO
    A.4.1Sponsor's protocol code number6996
    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 SponsorHôpitaux Universitaires de Strasbourg
    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 supportHôpitaux universitaires de Strasbourg
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportHospices Civils de Lyon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpitaux universitaires de Strasbourg
    B.5.2Functional name of contact pointErci DEMONSANT
    B.5.3 Address:
    B.5.3.1Street Address1 place de l'Hôpital
    B.5.3.2Town/ citySTRASBOURG
    B.5.3.3Post code67097
    B.5.3.4CountryFrance
    B.5.4Telephone number0033388115266
    B.5.5Fax number0033388115494
    B.5.6E-maildpidrci@chru-strasbourg.fr
    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 ZITHROMAX 250mg
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    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 Capsule
    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 INNAZITHROMYCIN
    D.3.9.1CAS number 83905-01-5
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB05660MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboCapsule
    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
    Periodontology
    Parodontologie
    E.1.1.1Medical condition in easily understood language
    Periodontology
    Parodontologie
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    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 evaluate the effect of azithromycin on the proportion of failures of non-surgical treatments for severe chronic periodontitis characterized by the persistence of at least one periodontal pocket > 5mm at 6 months.
    Evaluer l’effet de l'azithromycine sur la proportion d'échecs des traitements non-chirurgicaux des parodontites chroniques sévères, échecs caractérisés par la persistance d'au moins une poche parodontale > 5mm à 6 mois.
    E.2.2Secondary objectives of the trial
    - Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets >5mm during non-surgical treatments of severe chronic periodontitis at 3 and 6 months
    - Evaluate the effect of azithromycin on the evolution of clinical indices, periodontal flora, expression of macrolide resistance genes, and expression of antimicrobial peptides (MAPs) during the treatment of severe chronic periodontitis at 3 and 6 months
    - Assess compliance and side effects of antibiotic treatment
    - Evaluate the potential interactions of local clinical, bacterial (periodontal pathogens and resistance genes), and host defense (HDPs) factors with the effect of azithromycin on the proportion of failures of non-surgical treatments of severe chronic periodontitis at 3 and 6 months
    - Evaluer l’effet de l'azithromycine sur la persistance de poches parodontales pathologiques >5mm lors des traitements non-chirurgicaux des parodontites chroniques sévères à 3 mois et à 6 mois
    - Evaluer l’effet de l’azithromycine sur l’évolution des indices cliniques, de la flore parodontopathogène, l’expression de gènes de résistance aux macrolides, et l’expression des peptides antimicrobiens (PAMs) lors des traitements des parodontites chroniques sévères à 3 mois et à 6 mois
    - Evaluer l’observance thérapeutique et les effets secondaires du traitement antibiotique
    - Evaluer les interactions potentielles des facteurs cliniques locaux, bactériens (parodontopathogènes et gène de résistance), et de défense de l'hôte (PAMs) avec l'effet de l'azithromycine sur la proportion d'échecs des traitements non-chirurgicaux des parodontites chroniques sévères à 3 et 6 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 35 years of age
    - Patient with severe chronic periodontitis (loss of attachment ≥ 5mm) generalized (>30% sites) (AAP 1999 classification) and pockets > 5mm on at least 5% of sites
    - Presence of bleeding on the catheter (≥ 30%)
    - Patient with at least 15 teeth including 2 molars (excluding wisdom teeth)
    - Patient benefiting from a social protection system
    - Voluntary patient with informed consent
    - Patient âgé de plus de 35 ans
    - Patient présentant des parodontites chroniques sévères (perte d’attache ≥ 5mm) généralisées (>30% sites) (classification AAP 1999) et des poches > 5mm sur au moins 5% des sites
    - Présence de saignement au sondage (≥ 30%)
    - Patient avec au moins 15 dents dont 2 molaires (hors dents de sagesse)
    - Patient bénéficiant d’un régime de protection sociale
    - Patient volontaire ayant signé un consentement éclairé
    E.4Principal exclusion criteria
    - Patient with contraindications to treatment with azithromycin or its excipient: absolute contraindications are the history of allergy to macrolides or to one of the excipients used in this study, combination with ergot derivatives, cisapride, colchicine and severe liver failure (azithromycin being essentially eliminated by the bile ducts). Other contraindications are in patients at risk of cardiac arrhythmias (diagnosis of QT prolongation and/or concomitant treatments, electrolyte disorders (hypokalemia, hypomagnesia, cardiac arrhythmias, heart failure), severe renal failure, and some drug combinations (antivitamin K, statins)
    - Patient with aggressive periodontitis (AAP 1999 classification)
    - Patient smoking more than 10 cigarettes/day
    - Patient at risk of type B infection (endocarditis) or requiring antibiotic prophylaxis,
    - Patient who has received antibiotic treatment in the 6 months preceding the periodontal examination
    - Patient who has received anti-inflammatory treatment in the month preceding the periodontal examination and/or anti-inflammatory treatment for more than 3 consecutive days in the 3 months preceding the periodontal examination
    - Patient on or after drug treatment (cyclosporine and other anti-rejection, anti-epileptic, calcium channel blocker drugs) affecting periodontal status
    - Patient with pathologies affecting the periodontal state and/or the systemic or local inflammatory response, such as diabetes, infectious or non-infectious stomatitis, inflammatory and autoimmune diseases, immunosuppression
    - Patient with a prolonged oral hygiene disability (physical/psychic inability to brush teeth)
    - Patient with a dilapidated oral condition (untreated cavities, unrestated teeth), oral infectious foci whose management requires antibiotic treatment within 6 months
    - Patient who has had specialized periodontal treatment, curettage/surfacing, or periodontal surgery in the year preceding the examination.
    - Pregnant woman (controlled by a negative urine beta-HCG test at inclusion) or during breastfeeding
    - Patient with chronic infections that occur repeatedly (more than 3 times per year) and require antibiotics
    - Patients who received oral antiseptic treatment in the month prior to the examination
    - Patient with swallowing disorders
    - Patient included in another intervention research protocol, or in periods of exclusion (participation in observational research is still possible)
    - Patient under guardianship and safeguard of justice
    - Patient with a high risk of bleeding and/or INR>4.
    - Patient unable to cooperate or understand study and care instructions
    - Patient under guardianship, curatorship or guardianship
    - Patient avec contre-indications au traitement par l’azithromycine ou à son excipient : les contre-indications absolues sont les antécédents d'allergie aux macrolides ou à un des excipients utilisés pour cette étude, l'association avec les dérivés à l'ergot de seigle, la cisapride, la colchicine et les insuffisances hépatiques sévères (l'azithromycine étant essentiellement éliminée par les voies biliaires). Les autres contre-indications sont chez les patients à risque de survenue d'arythmie cardiaque (diagnostic d'un allongement de l'intervalle QT et/ou traitements concomitants, trouble electrolytique (hypokaliémie, hypomagnésie, arythmie cardiaque, insuffisance cardiaque), les insuffisances rénales sévères, et certaines associations médicamenteuses (antivitamine K, statines)
    - Patient présentant une parodontite agressive (classification AAP 1999)
    - Patient fumant plus de 10 cigarettes/jour
    - Patient à risque d'infection de type B (endocardites) ou nécessitant une antibioprophylaxie,
    - Patient ayant suivi un traitement antibiotique dans les 6 mois précédant l’examen parodontal
    - Patient ayant suivi un traitement anti-inflammatoire dans le mois précédant l’examen parodontal et/ou un traitement anti-inflammatoire de plus de 3 jours consécutifs dans les 3 mois précédant l’examen parodontal
    - Patient suivant ou ayant suivi un traitement médicamenteux (Ciclosporine et autres médicaments anti-rejet, antiépileptique, inhibiteur calcique) influant sur l’état parodontal
    - Patient présentant des pathologies influant sur l’état parodontal et/ou sur la réponse inflammatoire systémique ou locale, telles que diabète, stomatite infectieuse ou non, maladies inflammatoires et auto-immunes, immuno-dépression
    - Patient avec un handicap d'hygiène bucco-dentaire prolongé (impossibilité physique/psychique de se brosser les dents)
    - Patient présentant un état bucco-dentaire délabré (caries non traitées, dents non restaurées), des foyers infectieux bucco-dentaires dont la prise en charge nécessite un traitement antibiotique dans les 6 mois
    - Patient ayant eu un traitement parodontal spécialisé, un curetage/surfaçage, ou un traitement chirurgical parodontal dans l'année précédant l'examen.
    - Femme enceinte (contrôlée par un teste beta-HCG urinaire négatif à l’inclusion) ou en période d’allaitement
    - Patient présentant des infections chroniques à répétition (plus de 3 fois par an) nécessitant la prise d'antibiotiques
    - Patients ayant eu un traitement antiseptique oral dans le mois précédent l’examen
    - Patient présentant des troubles de la déglutition
    - Patient inclus dans un autre protocole de recherche interventionnelle, ou en période d’exclusion (la participation à une recherche observationnelle reste possible)
    - Patient sous tutelle et sous sauvegarde de justice
    - Patient avec un risque de saignement élevé et/ou INR>4.
    - Patient incapable de coopérer ou de comprendre les consignes liées à l’étude et aux soins
    - Patient sous tutelle, curatelle ou sauvegarde
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects showing treatment failure, failure defined by the persistence of at least one residual pocket >5mm at 6 months
    Proportion de sujets en échec du traitement, échec défini par la persistance d'au moins une poche résiduelle >5mm à 6 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.5.2Secondary end point(s)
    Quantitative evolution of supragingival biofilms (Silness and Löe Plate Index) and of 6 main periodontopathogenic bacteria (qPCR) in subgingival biofilms
    - Evolution of erm(F) gene expression (qPCR) in subgingival biofilms
    - Evolution of gingival expression of MAPs, alpha-defensin-1, beta-defensin-2 and -3 and cathelicidin LL-37 (RT-qPCR)
    - Evolution of periodontal pocket depths (mm) at 3 months and 6 months
    - Evolution of clinical attachment levels (mm) at 3 and 6 months
    - Evolution of clinical inflammation (Löe and Silness Gingival Index) at 3 and 6 months
    - Collection of adverse events
    - Evolution quantitative des biofilms supra-gingivaux (Indice de Plaque de Silness et Löe) et de 6 principales bactéries parodontopathogènes (qPCR) dans les biofilms sous-gingivaux
    - Evolution de l’expression du gène erm(F) (qPCR) dans les biofilms sous-gingivaux
    - Evolution de l’expression gingivale des PAMs, alpha-defensin-1, beta-defensin-2 et -3 et cathelicidin LL-37 (RT-qPCR)
    - Evolution des profondeurs des poches parodontales (mm) à 3 mois et 6 mois
    - Evolution des niveaux d’attache clinique (mm) à 3 et 6 mois
    - Evolution de l’inflammation clinique (Indice Gingival de Löe et Silness) à 3 et 6 mois
    - Recueil des évènements indésirables
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 3 and 6 months
    A 3 et 6 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    LVLS
    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 months42
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 Information not present in EudraCT
    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 state124
    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
    Aucun
    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 Decision2019-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-12-16
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