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    Summary
    EudraCT Number:2021-004038-12
    Sponsor's Protocol Code Number:19-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-10-14
    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 number2021-004038-12
    A.3Full title of the trial
    Randomized open-label controlled trial evaluating a single-dose intravenous Dalbavancin versus standard antibiotic therapy during catheter-related bloodstream infections due to Staphylococcus aureus
    Essai randomisé ouvert évaluant une dose unique de Dalbavancine comparée à un traitement antibiotique standard dans le traitement des bactériémies à Staphylococcus aureus associées aux cathéters veineux.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non Applicable
    A.3.2Name or abbreviated title of the trial where available
    DALICATH
    A.4.1Sponsor's protocol code number19-01
    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 SponsorCENTRE HOSPITALIER ANNECY GENEVOIS
    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 supportFrench Ministery of Health (DGOS)
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportADVANZ Pharma
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCENTRE HOSPITALIER ANNECY GENEVOIS
    B.5.2Functional name of contact pointMarion NORET
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue de l'Hôpital BP90074
    B.5.3.2Town/ cityEPAGNY METZ-TESSY
    B.5.3.3Post code74370
    B.5.3.4CountryFrance
    B.5.4Telephone number+33456497240
    B.5.6E-mailmnoret@ch-annecygenevois.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 Int. 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.3.1Product nameDalbavancin
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/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
    Staphylococcus aureus catheter bloodstream infection
    E.1.1.1Medical condition in easily understood language
    Bloodstream infection caused by the bacterium Staphylococcus aureus in patients with a catheter and with a low risk for S. aureus associated complications
    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, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines.
    E.2.2Secondary objectives of the trial
    1. Cure rate at DAY 14 and DAY 90;
    2. Mortality rate within 90 days of follow-up;
    3. Bloodstream clearance;
    4. Patient’s quality of life;
    5. Hospitalization length of stay;
    6. Cost-utility analyses;
    7. Occurrence of any adverse event (AE and SAE), until DAY 90

    Exploratory Objectives :
    1. Pharmacokinetics of dalbavancin will be performed for all patient randomized in the experimental arm (203 patients) to determine the residual concentration 14 days after dalbavancin injection.
    2. Analyses of all strains involved in CR-BSIs included in the trial will be centralized at the French “Centre National de Référence des Staphylocoques”, and will be comprised of determination of susceptibility to dalbavancin of each strain by broth dilution method and strains sero-types and virulence factors.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged at least 18 years;
    2. Blood cultures positive for S. aureus, obtained within 72 hours before randomization (the date considered is the date of the sampling, not the results);
    3. CR-BSI, defined as:
    One positive blood culture AND Local signs of infection at the catheter site
    OR
    at least one positive blood culture obtained from the catheter and the peripheral vein, AND A differential period between catheter versus peripheral blood culture positivity of at least 2h as recommended; AND Same S. aureus isolate (same phenotype) identified from the catheter and the peripheral vein blood cultures;
    3. Intravascular catheter – implantable venous access device (port-a-cath and Piccline) – removed before randomization;
    4. Informed consent form
    E.4Principal exclusion criteria
    1. Polymicrobial CR-BSI
    2. More than 72 hours of active antibiotic treatment targeting S. aureus (in-vitro susceptibility) administered prior to randomization;
    3. Patient with known valvulopathy, previous history of endocarditis, or suspicion of infective endocarditis by physician in charge;
    4. Suspicion of any other deep focus infections, such as arthritis, pneumonia, osteomyelitis, or meningitis, presence of cerebral or peripheral emboli (arterial occlusion);
    5. Thrombophlebitis
    6. Failure to remove any intravascular catheter which was present when first positive blood culture
    7. Signs of infection associated with qSOFA score ≥ 2 at randomization
    8. Patients with foreign bodies such as: prosthetic heart valve, endovascular prosthesis, ventriculo-atrial shunt, pacemaker, or an automated implantable cardioverter defibrillator (AICD) device
    9. Severe liver disease (Child-Pugh C)
    10. Severely immunocompromised patients:
    11. Contraindication to dalbavancin and/or glycopeptid
    12. Life expectancy < 3 months
    13. Injection drug user
    14. Pregnant or breastfeeding women
    15. For premenopausal women: failure to use highly-effective contraceptive methods for 1 month after receiving study drug
    16. Participation in other interventional trials within the previous three months or ongoing;
    17. Persons held in an institution by legal or official order;
    18. Patients under guardianship or curatorship;
    19. Patients unable to give a free and informed consent;
    20. Patient not affiliated to a social security scheme: obligation of affiliation to a social security scheme or to be a beneficiary.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical cure without relapse at Day 30, defined by the absence of all the following:
    - Local and/or general signs of infection:
    o local: redness, induration, swelling, purulent discharge;
    o general: fever, chills;
    - Relapse of bacteremia to S. aureus – i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials);
    - Any additional antibiotic therapy active on S. aureus received after DAY 14; i.e. between DAY 14 and DAY 30.
    - Deep focus infection including endocarditis
    - Death from all causes
    An independent endpoint committee, blinded to the groups of treatment, will evaluate the primary outcome, thanks to prespecified criteria in the protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after randomization
    E.5.2Secondary end point(s)
    1. Clinical cure at DAY 14 and DAY 90 defined by the absence of all the following:
    For DAY 14 and DAY 90:
    a. Local and/or general signs of infection:
    i. local: redness, induration, swelling, purulent discharge;
    ii. general: fever, chills;
    b. Relapse of bacteremia to S. aureus – i.e. a bacteremia due to S. aureus occurring after initial negativation of blood cultures (2 vials);
    c. Any additional antibiotic therapy active on S. aureus received between DAY 14 and DAY 90;
    2. Death all-cause occurring within 90 days of follow-up;
    3. Time from first positive blood culture to first negative blood cultures (in days), limited to DAY 14
    4. Autonomy, pain and anxiety using EQ-5D-5L scale at baseline (Day 0), DAY 14, DAY 30 and DAY 90
    5. Hospitalization duration in days;
    6. Cost per avoided relapse, life-year gained, and per quality-adjusted life year (QALY);
    7. Proportion of patients with any adverse event until DAY 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    DAY 14; DAY 30 ; DAY 90
    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 Yes
    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
    Standard documented antibiotic therapy for 14 days, as-per S. aureus susceptibility
    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 concerned35
    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 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
    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 months27
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 No
    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 state406
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation RENARCI
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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