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    Summary
    EudraCT Number:2007-001774-88
    Sponsor's Protocol Code Number:TAR-ORI-SD001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-09-05
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2007-001774-88
    A.3Full title of the trial
    Nuvocid™ (oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
    A.3.2Name or abbreviated title of the trial where available
    SIMPLIFI
    A.4.1Sponsor's protocol code numberTAR-ORI-SD001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTarganta Therapeutics Corporation
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNoritavancin
    D.3.9.1CAS number 192564-14-0
    D.3.9.2Current sponsor codeNUVOCID
    D.3.9.3Other descriptive nameoritavancin diphosphate, oritavancin bis(phosphate), oritavancin bis phosphate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAntiinfective/Antibiotic
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated skin and skin structure infections (cSSSI).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10040872
    E.1.2Term Skin infection
    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 evaluate the efficacy of either single dose or infrequent dosing regimens of IV oritavancin compared with daily IV dosing of 200 mg oritavancin for 3 to 7 days in the treatment of patients with cSSSI.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the safety of either single dose or infrequent dosing regimens of IV oritavancin compared with daily IV dosing of 200 mg oritavancin for 3 to 7 days in the treatment of patients with cSSSI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Patients must have a cSSSI, presumed or proven to be caused by gram-positive pathogen(s) that meet disease diagnostic criteria as defined in Section 9.1.1.
    [2] Patients, ages 18 years and older, with a BMI >17 kg/m2 and <40 kg/m2. Female patients of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a negative urine pregnancy test at the time of enrollment and must agree to a reliable method of birth control (eg, use of oral, intravaginal or transdermal contraceptives or Norplant®; a double-barrier method [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam]; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 6 months following the last dose of study drug.
    [3] Patient or a legally authorized representative must sign and date an approved IRB or IEC informed consent document.
    E.4Principal exclusion criteria
    [1] Underlying condition which, in the opinion of the Investigator, would preclude performing protocol safety and efficacy assessments. Patients with renal insufficiency may be included if renal function is stable.
    FINAL PROTOCOL Approved: 03-April-2007
    Confidential
    Targanta Therapeutics Corporation TAR-ORI-SD001
    Oritavancin diphosphate Page 31 of 71
    [2] Dosing with systemic antimicrobials for more than 24 hours within the last 3 days. However, a patient who has been treated for more than 24 hours may be enrolled if:
    • The gram-positive pathogen is resistant in vitro to the antimicrobial, OR
    • The patient with a proven or presumed gram-positive infection has failed to respond to antibiotic therapy and appropriate surgical management (eg, patient with presumed MRSA cellulitis who would have been changed to vancomycin, or patient with continued purulent draining from wound or abscess). Disease diagnostic criteria (see Section 9.1.1) and culture requirements (see Section 9.1.1) must still be met at the time of enrollment.
    [3] Any of the following entities:
    a. toxic shock syndrome or toxic-like syndrome (Mandell et al. 1995)
    b. presumed or proven infection caused by Clostridium species
    c. incisional wound or abscess that extends into visceral compartments
    d. contiguous bony involvement
    e. ischemic ulcers or wounds associated with arterial insufficiency or gangrene
    f. infections predominantly caused by aerobic or anaerobic gram-negative bacilli (i.e. decubitus ulcers or diabetic foot ulcers), unless a gram stain of an appropriate specimen indicates a predominance of gram-positive cocci
    g. infection of prosthetic materials that cannot be removed as part of the treatment of the current infection (see Section 10.6.2)
    h. infection of the scrotum, perineum or perianal region (eg, episiotomy infection, perianal cellulitis, or Fournier’s gangrene)
    i. infection of a full-thickness burn wound or burn wound that is approximately 20% or more of total body surface area
    j. malignant otitis externa
    k. infection following injury in water possibly containing Vibrio species or following a history of eating raw oysters within 1 week prior to disease onset
    l. secondary infection of a pre-existing skin disease that may interfere with the clinical evaluations during the study.
    [4] Pregnancy or lactating females who are nursing and will not consent to cease nursing for at least 6 months.
    [5] Patients that require, or are anticipated to require, continuous therapeutic doses of unfractionated heparin either by infusion or repeated bolus where dosing is to be monitored/adjusted based on aPTT levels. Note: Patients that require, or are anticipated to require, fractionated or low molecular weight heparin or on prophylactic doses of subcutaneous unfractionated heparin may be included.
    [6] Poor venous access that would preclude IV drug delivery or multiple blood draws.
    [7] History of severe hypersensitivity reactions to glycopeptides (eg, vancomycin) (including but not limited to erythema multiform major, linear Immunoglobulin-A (IgA) dermatosis, toxic epidermal necrolysis, exfoliative dermatitis). Note: patients who have had histamine-like infusion reactions to the glycopeptide vancomycin are not excluded (see Section 10.4.1).
    [8] Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
    [9] Patients unwilling to forego blood and/or blood product donation for at least 3 months.
    [10] Requirement for interventions as defined in Section 10.6.2 that cannot be instituted within 36 hours of enrollment.
    [11] Anticipated need for more than 10 days of conventional antibiotic therapy.
    [12] Targanta employees, Targanta designees, Investigator, and site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is clinical response (either cure or improvement versus failure) in clinically evaluable (CE) patients as assessed at the First Follow-Up time point.
    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 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.8.3 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The study will be considered completed at the time of the last patient Late Follow-Up evaluations.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent may be given by a patient's a legally authorized representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 294
    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 Decision2007-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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