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    Summary
    EudraCT Number:2010-024042-30
    Sponsor's Protocol Code Number:DUR001-301
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-024042-30
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO COMPARE THE EFFICACY AND SAFETY OF DALBAVANCIN TO A COMPARATOR REGIMEN (VANCOMYCIN AND LINEZOLID) FOR THE TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study of the investigational antibiotic dalbavancin compared to a standard antibiotic for the treatment of infections of the skin and nearby tissues.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of Dalbavancin for the Treatment of ABSSSI
    A.4.1Sponsor's protocol code numberDUR001-301
    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 SponsorDurata Therapeutics, 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 supportDurata Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDurata Therapeutics, Inc.
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address89 Headquarters Plaza North, 14th F
    B.5.3.2Town/ cityMorristown,
    B.5.3.3Post codeNJ 07960
    B.5.4Telephone number+1 973-993-4865
    B.5.5Fax number+1 973-993-4395
    B.5.6E-mailClinicalresearch@duratatherapeutics.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDalbavancin
    D.3.2Product code DUR001
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDalbavancin
    D.3.9.1CAS number 171500-79-1
    D.3.9.2Current sponsor codeDUR001
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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 Yes
    D.2.1.1.1Trade name Vancomycin 500 mg Powder for Solution for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderHospira
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameVancomycin
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVANCOMYCIN
    D.3.9.1CAS number 1404906
    D.3.9.3Other descriptive nameSterile Vancomycin Hydrochloride, USP,
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 3
    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 Yes
    D.2.1.1.1Trade name ZYVOX (linezolid) tablet, film coated
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia and Upjohn Company
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameZYVOX
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNLINEZOLID
    D.3.9.1CAS number 165800-03-3
    D.3.9.3Other descriptive nameLINEZOLID (Zyvox, Pharmacia and Upjohn, Div. of Pfizer Inc.)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    acute bacterial skin and skin structure infections (abSSSI)
    E.1.1.1Medical condition in easily understood language
    Acute infections of the skin and nearby soft tissue known or believed to be caused by a type of Gram positive bacteria.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10004035
    E.1.2Term Bacterial infection due to staphylococcus aureus
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen [vancomycin with the option to switch to oral linezolid (vancomycin/linezolid)] for the treatment of patients with a suspected or proven Gram-positive abSSSI.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To compare the clinical efficacy at the end of treatment visit (EOT) of dalbavancin to the comparator regimen.
    - To compare the per-patient microbiological efficacy of dalbavancin to the comparator regimen.
    - To compare clinical efficacy by individual pathogens in the two treatment groups.
    - To compare pathogen eradication rates for individual pathogens in the two treatment groups.
    - To compare the safety and tolerability of dalbavancin to that of the comparator regimen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female patients 18 - 85 years of age.
    2.A personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    3.Patients having an abSSSI (suspected or confirmed to be caused by Gram-positive bacteria) defined for purposes of this study as an infection either involving deeper soft tissue or requiring significant surgical intervention:
    (a)Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which:
    i. requires surgical incision and drainage, and
    ii. is associated with cellulitis such that the total affected area involves at least 75 cm2 of erythema, and
    iii. is defined by a margin of erythema that is ≥ 5 cm from the rim of induration or edema that defines the border of the abscess in all directions, or,
    iv. alternatively, involves the central face and is associated with an area of erythema of at least 50 cm2 and a margin ≥ 3 cm in all directions from the abscess rim
    (b)Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that
    i.the total affected area involves at least 75 cm2 of erythema, and
    ii.is defined by a margin of erythema in at least one direction that is ≥ 5 cm from the edge of the wound, or
    iii.alternatively, involves the central face and is associated with an affected area of at least 50 cm2 and has a margin of erythema in at least one direction ≥ 3 cm from the wound edge
    (c)Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and
    i.is associated with erythema that involves at least 75 cm2 of surface area, or
    ii.alternatively, cellulitis of the central face that is associated with an affected area of at least 50 cm2
    4.In addition to the requirement for erythema, all patients are required to have at least two (2) of the following signs of abSSSI
    •Purulent drainage/discharge
    •Fluctuance
    •Heat/localized warmth
    •Tenderness to palpation
    •Swelling/induration
    5.Patients must present with at least ONE of the following systemic signs of infection:
    (a) An elevated body temperature ≥38 degrees Centigrade/100.4 degrees Fahrenheit as measured by the patient/caregiver or investigator within 24 hours of baseline;
    (b) White blood cell count > 12,000 cells/mm3;
    (c) A manually performed white blood differential count with ≥ 10% band forms, regardless of peripheral white blood cell count.
    6.Infection severity such that a minimum of 3 days of IV therapy is appropriate for management of the abSSSI.
    7.Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will be excluded from the study:
    1.A contra-indication to the administration of dalbavancin, vancomycin, or linezolid, such as hypersensitivity to any of the agents.
    2.Females of child-bearing potential who are unable to take adequate contraceptive precautions, have a positive pregnancy result within 24 hours prior to study entry, are known to be pregnant, or are currently breastfeeding an infant.
    3.Sustained shock, defined as systolic blood pressure <90 mm Hg for more than 2 hr despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
    4.Participation in another study of an investigational drug or device within 30 days before this study begins.
    5.Receipt of a systemically or topically administered antibiotic with a gram positive spectrum that achieves therapeutic concentrations in the serum or at the site of the abSSSI within 14 days prior to randomization (Exception: patients receiving a single dose of a short-acting (half-life ≤12 hr) antibacterial drug 3 or more days prior to randomization (e.g., administration of a single dose of an antibacterial drug for surgical prophylaxis).
    6.Infection due to an organism known prior to study entry to be resistant to dalbavancin or vancomycin (vancomycin mean inhibitory concentration (MIC) > 8 microgram/ml).
    7.Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis; endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
    8.Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
    9.Venous catheter entry site infection.
    10.Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
    11.An infected device, even if the device is removed (eg, prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis catheter, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter).
    12.Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram positive bacteremia.
    13.Patient's abSSSI is the result of having sustained full or partial thickness burns.
    14.An infection involving a limb with evidence of critical ischemia of an affected limb (ie, absent or abnormal Doppler wave forms, toe blood pressure of < 45 mm Hg, ankle brachial index < 0.5, and/ or critical ischemia as assessed by a vascular surgeon).
    15.Patient's abSSSI (ie, superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess) that only requires surgical drainage for cure.
    16.Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
    17.Anticipated need of antibiotic therapy for longer than 14 days.
    18.Placement in a hyperbaric chamber as adjunctive therapy for the abSSSI.
    19.More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the abSSSI, or patients who are expected to require more than 2 such interventions.
    20.Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (eg, chronic stasis dermatitis of the lower extremity).
    21.Absolute neutrophil count <500 cells/mm3.
    22.Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 and/or with past or current AIDS-defining condition
    23.A recent bone marrow transplant (in post-transplant hospital stay).
    24.Receiving oral steroids > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
    25.Receiving an antipyretic drug on a daily basis (eg, daily use of naproxen) whose regimen cannot be modified during the first three days of study drug therapy.
    26.A rapidly fatal illness, who are not expected to survive for 3 months.
    27.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    28.Prior participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is clinical response at 48-72 hours post study drug initiation, as defined programmatically based on measurements of abSSSI lesion size and temperature
    E.5.1.1Timepoint(s) of evaluation of this end point
    48-72 hours
    E.5.2Secondary end point(s)
    A secondary outcome is clinical status at the EOT Visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    study day 14-15
    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 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) 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 concerned6
    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 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
    Canada
    Croatia
    Georgia
    Russian Federation
    Serbia
    Ukraine
    United States
    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
    Please refer to protocol section 13
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 556
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 556
    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 state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 556
    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)
    Patients will be referred to their physician for follow up or if additional treatment is required.
    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 Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-07
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