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    Summary
    EudraCT Number:2020-003169-20
    Sponsor's Protocol Code Number:20-AOI-03
    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:2020-07-22
    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 number2020-003169-20
    A.3Full title of the trial
    Efficacy of dalbavancin during osteo-articular infections associated with hip and knee prostheses
    Efficacité de la dalbavancine au cours des infections ostéo-articulaires associées aux prothèses (IOAP) de hanche et de genou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of dalbavancin during osteo-articular infections associated with hip and knee prostheses
    Efficacité de la dalbavancine au cours des infections ostéo-articulaires associées aux prothèses (IOAP) de hanche et de genou
    A.3.2Name or abbreviated title of the trial where available
    PRO-DALBA
    PRO-DALBA
    A.4.1Sponsor's protocol code number20-AOI-03
    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 de Nice
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address4 Avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone number33492034011
    B.5.5Fax number33492034575
    B.5.6E-maildrc@chu-nice.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 XYDALBA
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals International Ltd.
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Osteo-articular infections
    Infections ostéo-articulaires associées aux prothèses
    E.1.1.1Medical condition in easily understood language
    Osteo-articular infections
    Infections ostéo-articulaires associées aux prothèses
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10075981
    E.1.2Term Staphylococcus aureus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Describe the efficacy of dalbavancin in combination with rifampicin in the treatment of staphylococcal or streptococcal osteo-articular infections associated with hip and knee prostheses 12 months after surgery.
    Décrire l’efficacité de la dalbavancine en association à la rifampicine au cours du traitement des IOAP à staphylocoques ou streptocoques associées aux prothèses de hanche et de genou 12 mois après la prise en charge chirurgicale.
    E.2.2Secondary objectives of the trial
    1. Describe the efficacy of dalbavancin in combination with rifampicin during the treatment of staphylococcal or streptococcal osteo-articular infections associated with hip and knee prostheses 24 months after surgery
    2. Tolerance of dalbavancin within 6 months of administration
    3. Describe, at 12 and 24 months, the efficacy of dalbavancin in osteo-articular infections separately according to the germ involved, staphylococcus or streptococcus.
    4. Study of the association between residual dosage of dalbavancin at the end of treatment and clinical course at 12 and 24 months
    1. Décrire l’efficacité de la dalbavancine en association à la rifampicine au cours du traitement des IOAP à staphylocoques ou streptocoques associées aux prothèses de hanche et de genou 24 mois après la prise en charge chirurgicale.
    2. Tolérance de la dalbavancine dans les 6 mois suivant son administration
    3. Décrire, à 12 et 24 mois, l’efficacité de la dalbavancine dans les IOAP séparément selon le germe impliqué, staphylocoque ou streptocoque.
    4. Etude de l’association entre dosage résiduel de dalbavancine en fin de traitement et évolution clinique à 12 et 24 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged ≥ 18
    - osteo-articular infections of knee prosthesis or hip, monomicrobial, staphylococcus or streptococcus sensitive to dalbavancin (determined by an MIC by microdilution of the strain in question for vancomycin ≤ 2mg/L) and rifampicin, treated surgically by DAIR with change of moving parts (acute infections) or change in 1 step (chronic infections)
    - Social security affiliation
    - Signature of informed consent
    - Age ≥ 18 ans
    - IOAP de prothèse de genou (PTG) ou de hanche (PTH) monomicrobienne, à staphylocoque ou streptocoque sensible à la dalbavancine (déterminée grâce à une CMI par microdilution de la souche en cause pour la vancomycine ≤ 2mg/L) et à la rifampicine, traitée chirurgicalement par DAIR avec changement des pièces mobiles (infections aiguë) ou changement en 1 temps (infections chroniques)
    - Affiliation à la sécurité sociale
    - Signature du consentement éclairé
    E.4Principal exclusion criteria
    - Hypersensibilité aux glycopeptides ou à la rifampicine ou à l’un des excipients
    - Porphyries
    - Traitement antibiotique probabiliste non administré dans les 24h suivant la chirurgie
    - Traitement antibiotique probabiliste n’ayant pas pris en considération dans son spectre la bactérie à l’origine de l’infection
    - Infection aiguë hématogène (secondaire aiguë)
    - Prise d’un traitement de fond incompatible avec l’effet inducteur de la rifampicine (cf RCP de la rifampicine)
    - Cirrhose hépatique
    - Prise de traitement ototoxique, comme un aminoside
    - Fonction rénale avec un débit de filtration glomérulaire mesuré par MDRD inférieur à 30 ml/min
    - Femmes enceintes et allaitantes
    - Personnes protégées définies dans les articles suivants du code de la santé publique :
    L. 1121-6 : personnes privées de liberté par une décision judiciaire ou administrative, personnes hospitalisées sans consentement et personnes admises dans un établissement sanitaire ou social à d’autres fins que celle de la recherche ;
    L. 1121-8 : personnes majeures faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer leur consentement ;
    L. 1122-1-2 : personnes en situations d’urgence ne pouvant pas donner un consentement préalable.
    - Hypersensitivity to glycopeptides or rifampicin or to any of the excipients
    - Porphyrias
    - Probabilistic antibiotic treatment not administered within 24 hours of surgery
    - Probabilistic antibiotic treatment that did not take into account in its spectrum the bacteria causing the infection
    - Acute hematogenous infection (acute secondary)
    - Taking a basic treatment incompatible with the inducing effect of rifampicin (see SPC of rifampicin)
    - Hepatic cirrhosis
    - Taking ototoxic treatment, such as an aminoglycoside
    - Kidney function with a glomerular filtration rate measured by MDRD less than 30 ml / min
    - Pregnant and lactating women
    - Protected persons defined in the following articles of the public health code:
    L. 1121-6: persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research;
    L. 1121-8: adults who are subject to legal protection measures or out of state to express their consent;
    L. 1122-1-2: people in emergency situations who cannot give prior consent.
    E.5 End points
    E.5.1Primary end point(s)
    Success is defined by the absence of failure within 12 months of surgery
    Le succès est défini par l’absence d’échec dans les 12 mois suivant la prise en charge chirurgicale
    E.5.1.1Timepoint(s) of evaluation of this end point
    within 12 months of surgery
    Dans les 12 mois suivant la prise en charge chirurgicale
    E.5.2Secondary end point(s)
    1. Success is defined by the absence of failure within 24 months of surgery
    2. Tolerance will be assessed by collecting adverse reactions during treatment with dalbavancin and rifampicin classified according to the CTCAE (version 5.0) within 6 months of its first administration.
    3. Describe at 12 and 24 months the success rate of treatment with dalbavancin according to microbiological data (in the staphylococcus and streptococcus subgroups).
    4. Residual dosage of dalbavancin on D61
    1. Le succès est défini par l’absence d’échec dans les 24 mois suivant la prise en charge chirurgicale
    2. La tolérance sera évaluée par le recueil des effets indésirables durant le traitement par dalbavancine et rifampicine classés selon la CTCAE (version 5.0) dans les 6 mois suivant sa première administration.
    3. Décrire à 12 et 24 mois le taux de succès du traitement par dalbavancine selon les données microbiologiques (dans les sous-groupes staphylocoques et streptocoques).
    4. Dosage résiduel de dalbavancine à J61
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 24 months of surgery
    Within 6 months of its first administration
    12 and 24 months
    Day 61
    Dans les 24 mois suivant la prise en charge chirurgicale
    Dans les 6 mois suivant sa première administration
    12 et 24 mois
    Jour 61
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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 concerned3
    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
    E.8.9.2In all countries concerned by the trial months42
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state43
    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 Decision2020-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-01
    P. End of Trial
    P.End of Trial StatusOngoing
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